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

Model Number	72202088
Medical Device Problem Codes	Crack (1135); Poor Quality Image (1408); Optical Obstruction (3002)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 the set up before a hip scope, the scope had a crack and the vision was blurry.A delay greater than 30 minutes was reported and the patient was already under anesthesia.Another smith and nephew back-up device with a different part number was used to complete the surgery.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a cracked weld, a loose prism, and a cracked negative lens.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The ifu, arthroscopes/ent endoscopes was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of capas, ncs, pra/hhes, and field actions found no prior escalation actions applicable to the complaint.The complaint was confirmed, and the root cause was associated with an unintended use of the device.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during a hip scope, the scope had a crack and the vision was blurry.A delay greater than 30 minutes was reported.Another smith and nephew back-up device was available to complete the surgery.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 b5 and h6: event description and f code updated.

• 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: 10702872
• Report Number: 3003604053-2020-00132
• Device Sequence Number: 16873142
• 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
• Serviced by Third Party (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?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/17/2022; 04/08/2024
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/18/2022; 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown