Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

Dec 14, 2020 Surgical Instruments Nationwide View Details →

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

Zimmer Biomet

Class I - Dangerous

Device has the potential for fracture during use.

Nov 20, 2020 Surgical Instruments Nationwide View Details →

IceRod" 1.5 i-Thaw" Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

IceSeed" 1.5 90¿ Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

IceSeed" 1.5 MRI Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

GA HEALTH COMPANY LIMITED

Class I - Dangerous

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Nov 3, 2020 Surgical Instruments Nationwide View Details →

IceSphere" 1.5 CX 90¿ Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

IceSphere" 1.5 Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

IceSphere" 1.5 S 90¿ Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

IceFORCE" 2.1 CX 90¿ Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

IceRod" 1.5 PLUS 90¿ Cryoablation Needle

Boston Scientific

Class I - Dangerous

Complaint trend regarding needle shaft gas leaks.

Nov 18, 2020 Surgical Instruments Nationwide View Details →

Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

Integra LifeSciences

Class I - Dangerous

Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

Dec 14, 2020 Surgical Instruments Nationwide View Details →

Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

Haag-Streit USA

Class I - Dangerous

Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye

Nov 20, 2020 Surgical Instruments Nationwide View Details →