MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS 4K A/C CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72205058

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2020

Event Type  malfunction  

Event Description

It was reported that during a knee scope procedure, the camera head presented lot of brightness.Backup device was available to complete the procedure.Delay greater than 30 minutes was reported.However, no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was returned to the designated complaint station for independent evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional test revealed that the displayed image is bright and does not respond to the electronic level control function.The complaint was confirmed and the root cause has been associated with a component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures.Factors, unrelated to the manufacturing and design of the device that could have contributed to the damage, include a failing cable or sensor component.No containment or corrective actions are recommended at this time.

• Brand Name: LENS 4K A/C CAMERA HEAD
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10236874
• MDR Text Key: 198112104
• Report Number: 1643264-2020-00478
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556720790
• UDI-Public: 00885556720790
• Combination Product (y/n): N
• PMA/PMN Number: K191177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205058
• Device Catalogue Number: 72205058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1