MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72204354

Device Problem Unexpected Shutdown (4019)

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 video picture quality of the camera head became so poor that all the surgeons could not realistically identify the proper anatomy during the procedures.It reached the point that dr.(b)(6) had to perform an open procedure for a shoulder case that had occurred approximately 8 weeks ago which should and could have been done arthroscopically.Prior to this, he had been having compromised quality since november but had been able to complete the cases.Inadequate performance of the smith and nephew equipment added significant time to the cases causing an increased open wound and increased anesthesia time thus adding increased costs to the center in overtime for anesthesia and personnel.Dr.(b)(6) said that they spent more time working on getting the equipment to function properly than concentrating on the case at hand.There were no patients injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specifications or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended by post-market surveillance to assess for any necessary corrective actions.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: LENS INTEGRATED SYSTEM WIFI VERSION
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9457760
• MDR Text Key: 175907459
• Report Number: 1643264-2019-00876
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556617878
• UDI-Public: 00885556617878
• Combination Product (y/n): N
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204354
• Device Catalogue Number: 72204354
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1