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

Catalog Number 72203967S

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

It was reported that the camera head lens was not working.No case reported; therefore, there was no patient involvement.Preliminary results of investigation have showed that the camera head live video was intermittent which made this a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was returned for independent evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional evaluation revealed there was a rattle heard in the head housing.Live video is intermittent and shows a split screen image.The complaint was confirmed and a root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the failure include internal damage to the cord.

• 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
• MDR Report Key: 10261804
• MDR Text Key: 198488725
• Report Number: 1643264-2020-00533
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556631980
• UDI-Public: 885556631980
• Combination Product (y/n): N
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203967S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1