MAUDE Adverse Event Report: SERVICE REPL CAMERA HEAD LENS INT SYS; ARTHROSCOPE

Model Number	72203967S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use, outside the patient, the camera head lens int sys has black screen.The procedure was finished with a smith and nephew backup device.No surgical delay.Patient injuries were not reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed the device was not recognized when plugged in.Further investigation revealed an internal damage to the cord.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event include a damaged cord.A review of the device history records showed there were no indications to suggest that the device did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: SERVICE REPL CAMERA HEAD LENS INT SYS
• Common Device Name: ARTHROSCOPE
• MDR Report Key: 12198041
• Report Number: 1643264-2021-02215
• Device Sequence Number: 17355549
• Product Code: HRX
• UDI-Device Identifier: 00885556631980
• UDI-Public: 00885556631980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 72203967S
• Device Catalogue Number: 72203967S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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