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

Model Number 72202088

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2020

Event Type  Injury  

Event 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.

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 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.

• Brand Name: ASCOPE ACLAVE HD 4MM X 70 DEG
• Type of Device: ARTHROSCOPE
• MDR Report Key: 10491718
• Report Number: 3003604053-2020-00096
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010616876
• UDI-Public: 03596010616876
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 72202088
• Device Catalogue Number: 72202088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown