MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 70°, 4MM; ARTHROSCOPE

Model Number	72202088S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that there was garbage inside the scope.There was a delay of more than 30 minutes.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.

• Brand Name: SERV REPL, A'SCOPE, A/C, HD, 70°, 4MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7533735
• Report Number: 3003604053-2018-00076
• Device Sequence Number: 16772449
• Product Code: HRX
• UDI-Device Identifier: 03596010645005
• UDI-Public: (01)03596010645005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 72202088S
• Device Catalogue Number: 72202088S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1