MAUDE Adverse Event Report: VIDEOARTHROSCOPE HD 4MM X 30 DEG

Model Number	72202961
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a arthroscopic rotator cuff repair, the video arthroscope was spoilt, it was separated into two parts and was not able to screw back.The procedure was completed with a significant delay greater than 30 minutes.A backup device was available and 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
D4 updated.Serial number added and lot number should be blank.
Additional Manufacturer Narrative
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.There was a relationship found between the returned device and the reported incident.A review of the customer provided image confirmed the scope was separated into two parts.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed and the root cause has been associated with a component failure.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.
Additional Manufacturer Narrative
H3, h6: 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 bent and dented needle, distal tip and fiber damage, broken lenses, and damaged coupler.A review of the customer provided image confirmed the scope was separated into two parts.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A clinical/medical evaluation found no relevant clinical information was provided.The surgeon changed the procedure and the device to complete the procedure with a significant delay.No other complications were reported.The complaint was confirmed.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.

• Brand Name: VIDEOARTHROSCOPE HD 4MM X 30 DEG
• Common Device Name: ARTHROSCOPE
• MDR Report Key: 10912540
• Report Number: 3003604053-2020-00155
• Device Sequence Number: 3317223
• Product Code: HRX
• UDI-Device Identifier: 00885554024159
• UDI-Public: 00885554024159
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K043395
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202961
• Device Catalogue Number: 72202961
• Device Lot Number: 050420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 01/22/2021; 11/01/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/02/2020; 01/26/2021; 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