MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,1.9,0,60,CW_STORZ; ARTHROSCOPE

Catalog Number	242047
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
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.H11 additional narrative: h4: the device manufacture date is currently unavailable.Investigation summary: the product has been returned to j&j medtech orthopaedics, also, a photo was provided for evaluation.Visual inspection of the returned photo found the shaft deformed at the proximal end.No other anomaly could be observed.The overall complaint was confirmed as the observed condition of the hd epscp, 1.9, 0, 60, cw_storz would have contributed to the complained device issue.Based on the investigation findings, a potential cause cannot be established.Multiple factors are associated with this type of failure, and the complaint device needs to be physically received and evaluated in our service center to determine a potential cause of why the customer experienced the failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during sterilization it was observed that the camera of the hd epscp, 1.9, 0, 60, cw_storz scope device had a blurry image and was bent.This event did not occur during a surgical procedure.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.
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.H11 additional narrative: investigation summary = > the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: visual : deformed/bent and broken (2+ pieces) : chipped/shaved/delaminated.- outer tube damaged, needle outer tube bent badly.- outer tube damaged, distal tip distal tip damaged minor scratches,nicks.- outer tube body / light post sidearm damaged nicks/dings.- laser welding damaged, needle bulge at base.- illumination distal tip fiber damaged.- particulate, optics particulate under distal lens particulate under proximal lens.- optical system, optical components optical system loose broken lenses in optical system black optics.Per service reports, this complaint was confirmed.The defective parts need to be replaced to resolve the issues.Based on the investigation findings, the potential root cause is traced to faulty parts.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device serial number, and no non-conformance was identified.
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.H11 additional narrative: investigational summary- the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: visual: deformed/bent and broken (2+ pieces): chipped/shaved/delaminated.- outer tube damaged, needle outer tube bent badly - outer tube damaged, distal tip distal tip damaged minor scratches, nicks - outer tube body / light post sidearm damaged nicks/dings - laser welding damaged, needle bulge at base - illumination distal tip fiber damaged - particulate, optics particulate under distal lens particulate under proximal lens - optical system, optical components optical system loose broken lenses in optical system black optics.Per service reports, this complaint was confirmed.Based on service manual operational and diagnostic, the device was found to be non-repairable, and it was scrapping.Based on the investigation findings, the potential root cause is traced to faulty parts.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device serial number, and no non-conformance was identified.

• Brand Name: HD EPSCP,1.9,0,60,CW_STORZ
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 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: 21892018
• Report Number: 1221934-2025-01400
• Device Sequence Number: 8154628
• Product Code: HRX
• UDI-Device Identifier: 10886705028092
• UDI-Public: (01)10886705028092
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 242047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 09/12/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/30/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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
• Patient Sex: Unknown