MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,0,175,CW_STORZ; ARTHROSCOPE

Catalog Number	242005
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: e3: reporter is a j&j employee.H4: the device manufacture date is currently unavailable.Investigation summary the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: outer tube damaged, outer tube bent.Broken lenses in optical system.Per service reports, this complaint can be confirmed.The device was scrapped as the system was non-repairable.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).
Event or Problem Description
It was reported by the j&j employee that during a large training event for an endoscopic sinus surgery on (b)(6) 2023, it was discovered that 3 of the hd ep arthroscope/sinuscope compatible with storz style 4.0mm x 0 deg x 175mm devices were not working properly.During an in-house engineering evaluation, it was determined that one of the devices was fractured.The devices were not for human use, therefore there was no patient involvement.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: HD EPSCP,4.0,0,175,CW_STORZ
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18552075
• Report Number: 1221934-2024-00189
• Device Sequence Number: 7597526
• Product Code: HRX
• UDI-Device Identifier: 10886705028764
• UDI-Public: 10886705028764
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• 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
• Report Date (Section B): 01/22/2024

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 Catalogue Number: 242005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown