MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COUPLER HD 17.2MM AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72204725
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is foggy due to it has water inside the coupler.No patient injury or significant delay were reported.The procedure was completed with the same device.
Event or Problem Description
It was reported that the device is foggy due to it has water inside the coupler.No patient injury or significant delay were reported.No back up device was available.
Event or Problem Description
It was reported that, during an unknown surgery, the coupler was noticed as foggy because there was water inside of the device.It is unknown how the procedure was completed as there was not any back up device available.No patient injury or significant delay were reported.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device has a foggy view.A visual inspection was performed and showed the camera coupler leaked.The point of entry for the moisture is on the proximal window brazing joint.The window also has fractures in the sapphire.A supplier corrective and preventative action was opened to address the leaking failure.A process change was completed.This serial number (b)(6) was manufactured before the change.Smith and nephew will continue to monitor this failure.

• Brand Name: COUPLER HD 17.2MM AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8584677
• Report Number: 3003604053-2019-00056
• Device Sequence Number: 1667431
• Product Code: GCJ
• UDI-Device Identifier: 00885556616727
• UDI-Public: 00885556616727
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72204725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 07/01/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/09/2019; 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1