MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASCOPE ACLAVE HD 4MM X 70 DEG; ARTHROSCOPE

Model Number	72202088
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up the scope was completely black and will not provide any view.It is unknown how was the procedure completed and a delay greater than 30 minutes was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the scope to have severe distal tip and fiber damage, a cracked negative lens and a loose prism.Since there was no harm alleged to this patient no further clinical/medical assessment is warranted at this time.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions this failure is confirmed not originate from manufacturing, packaging, or labeling defects.This damage is caused by contact with another source.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).B5 and h6: event description, annex f and e codes updated.
Event or Problem Description
It was reported that during a hip scope, the scope was completely black and will not provide any view.A delay greater than 30 minutes was reported.Another smith and nephew back-up device was available to complete the surgery.

• Brand Name: ASCOPE ACLAVE HD 4MM X 70 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10706133
• Report Number: 3003604053-2020-00134
• Device Sequence Number: 2917370
• Product Code: HRX
• UDI-Device Identifier: 03596010616876
• UDI-Public: 03596010616876
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2024

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: 72202088
• Device Catalogue Number: 72202088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 03/26/2021; 04/08/2024
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 03/27/2021; 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown