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

Catalog Number 72204725

Device Problems Image Display Error/Artifact (1304); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/1901

Event Type  malfunction  

Event 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 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 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.

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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8584677
• MDR Text Key: 144252709
• Report Number: 3003604053-2019-00056
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556616727
• UDI-Public: 00885556616727
• 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,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1