MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP,2.7X70D SH,25MM,FL; ARTHROSCOPE

Model Number	4132S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was not focusing.No patient injury was reported.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint that the device was not focusing.A visual inspection was performed and showed the scope to have damaged negative lens, tight focus ring with distal tip and fiber damage.This is caused by contact with another source.No manufacturing related defects were observed.
Event or Problem Description
It was reported that the device was not focusing and there was not back up available.No patient injury was reported.

• Brand Name: SERVICE REP,2.7X70D SH,25MM,FL
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7223965
• Report Number: 3003604053-2018-00016
• Device Sequence Number: 19138365
• Product Code: HRX
• UDI-Device Identifier: 00885556606650
• UDI-Public: (01)00885556606650
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K971253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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 Model Number: 4132S
• Device Catalogue Number: 4132S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/28/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR