MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LARYNGOSCOPE, ENDOSCOPE

Model Number 72204354

Device Problem Optical Problem (3001)

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

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy, the lens integrated system turned off and no longer works.The procedure was successfully completed with a backup device and no delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.The reported complaint of power loss could not be duplicated during the functional testing process.Ccu passed all functional testing and 4 hour burn-in inside of test tower.All video outputs and functions performed as expected.The complaint of power loss was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.

• Brand Name: LENS INTEGRATED SYSTEM WIFI VERSION
• Type of Device: LARYNGOSCOPE, ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10151358
• MDR Text Key: 195470215
• Report Number: 1643264-2020-00341
• Device Sequence Number: 1
• Product Code: GCI
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Distributor Facility Aware Date: 05/20/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1