MAUDE Adverse Event Report: ASCOPE ACLAVE HD 4MM X 70 DEG; ARTHROSCOPE

Model Number	72202088
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon forcefully inserted the scope/cannula via slotted cannula as a guide.There was a slight internal crack of distal scope lens.Likely, due to the amount of pressure the slotted cannula placed on the scope lens.The malfunction was solved with a delay shorter than 30 minutes with no patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.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 no related failures.The risk management files contain the reported failure mode.No update required.The instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Factors that are known to contribute to the alleged fault/failure may include mishandling during shipping, use or reuse of the device, contact with another source, or wear and tear over time.If the product is returned in the future the complaint can be reopened and evaluated.No further investigation is required.H11.Corrected information in b5.
Event or Problem Description
It was reported that the surgeon forcefully inserted the scope/cannula via slotted cannula as a guide.There was a slight internal crack of distal scope lens.Likely, due to the amount of pressure the slotted cannula placed on the scope lens.The malfunction was solved with a delay shorter than 30 minutes with no patient harm using a back up device and no fragments remain in joints.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 bent needle, distal tip damage, broken lens, loose prism and inner assembly.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 an isolated event.The instructions for use 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 risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.

• Brand Name: ASCOPE ACLAVE HD 4MM X 70 DEG
• Common Device Name: ARTHROSCOPE
• MDR Report Key: 10491718
• Report Number: 3003604053-2020-00096
• Device Sequence Number: 2889113
• Product Code: HRX
• UDI-Device Identifier: 03596010616876
• UDI-Public: 03596010616876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 10/29/2021
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/25/2020; 11/03/2021
• 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