FDA Adverse Event Malfunction Summary report: N

LENS 4K A/C CAMERA HEAD

MDR report key: 11809019 · Received May 11, 2021

Report

Report Number: 1643264-2021-01787
Event Type: Malfunction
Date Received: May 11, 2021
Date of Event: April 21, 2021
Report Date: June 14, 2021
Manufacturer: SMITH & NEPHEW, INC.
Product Code: GCJ
UDI-DI: 00885556720790
PMA / PMN Number: K191177
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT IDENTIFY ANY ISSUES. FUNCTIONAL EVALUATION REVEALED THAT THERE WAS LOSS OF IMAGE WHEN THE CONNECTOR IS MOVED. THE COMPLAINT HAS BEEN CONFIRMED AND THE ROOT CAUSE HAS BEEN ASSOCIATED WITH AN ELECTRICAL COMPONENT FAILURE. FACTORS, UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT, INCLUDE A DAMAGED CONNECTOR. 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 CONCLUDED THIS WAS A REPEAT ISSUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LENS (LENS 4K A/C CAMERA HEAD) WAS NOT ABLE TO GET A PICTURE. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
700834	LENS 4K A/C CAMERA HEAD	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	SMITH & NEPHEW, INC.	72205058		00885556720790

Patients

Seq	Age	Sex	Outcome	Treatment
1