MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 30 DEG 4MM; ARTHROSCOPE

Model Number 72202087S

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the scope presented no image, just black.It is unknown whether the event happened during surgery and if there was a patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.This event did not involve a serious injury or death and the malfunction ¿no image¿ in the product family ¿scopes¿ has no history of adverse events in the past, therefore this event is considered not reportable.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SERV REPL ASCOPE A/C HD 30 DEG 4MM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10732221
• MDR Text Key: 213025406
• Report Number: 3003604053-2020-00137
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010644534
• UDI-Public: 03596010644534
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202087S
• Device Catalogue Number: 72202087S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1