MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72203967S

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and a damaged edge connector was observed.A functional evaluation revealed that the device switched from the color bars to live video where it displayed a black screen.The complaint has been confirmed and the root cause has been associated with an electrical 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 concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

Event Description

It was reported that there was fog inside the camera head.It is unknown whether the event happened during surgery and if there was a patient involvement.Results of investigation have concluded that this unit was displaying a black screen which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SERVICE REPL CAMERA HEAD LENS INT SYS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10547890
• MDR Text Key: 207364378
• Report Number: 1643264-2020-01198
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556631980
• UDI-Public: 00885556631980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2020

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: 72203967S
• Device Catalogue Number: 72203967S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1