MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASCOPE ACLAVE HD 4MM X 30 DEG; ARTHROSCOPE

Model Number	72202087
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during headdress repair surgery, the lens at the end of the optic in the arthroscope 30-degree autoclavable was cracked and provided a black image.A backup device was available to complete the procedure with no significant delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: ASCOPE ACLAVE HD 4MM X 30 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11723287
• Report Number: 3003604053-2021-00169
• Device Sequence Number: 14364233
• Product Code: HRX
• UDI-Device Identifier: 03596010616869
• UDI-Public: 03596010616869
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 72202087
• Device Catalogue Number: 72202087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1