MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4K EPSCP SCP,4.0,30,167,MITEK; ARTHROSCOPE

Catalog Number	242137
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder repair surgery, it was observed that the 4k epscp scp,4.0,30,167,mitek device lens was dark.Another like device was used to complete the procedure.There was a five minute delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: h4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: h4: the device manufacture date was reported as unknown in the initial report.Please note that the date of manufacture has been updated accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was not returned to depuy synthes, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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 depuy synthes 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.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: repair level 3 major repair - other damages caused by customer - outer tube damaged, needle scratched - outer tube damaged, distal tip distal tip damaged dings/ scratched/sharp/dent - illumination distal tip fiber damaged - optical system, optical components broken lenses in optical system distal cover glass/negative damaged scratched/chipped - cosmetic issue scratches/dents - engraving/identification paint missing in engraving datamatrix code level a visual : scratched/nicked, broken (2+ pieces) : chipped/shaved/delaminated, visual : deformed/bent, labeling : illegible etch 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 depuy synthes 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 (b)(6), and no non-conformance was identified.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11: additional narrative: corrected: d4: serial number and primary udi number updated.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11: additional narrative: correction: updated investigation summary: investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: - other damages caused by customer - outer tube damaged, needle scratched - outer tube damaged, distal tip distal tip damaged dings/ scratched/sharp/dent - illumination distal tip fiber damaged - optical system, optical components broken lenses in optical system distal cover glass/negative damaged scratched/chipped - cosmetic issue scratches/dents - engraving/identification paint missing in engraving datamatrix code level a.Visual : scratched/nicked, broken (2+ pieces) : chipped/shaved/delaminated, visual : deformed/bent, labeling : illegible etch.Per service report, this complaint was confirmed.The housing, optical, tube and label were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Based on the investigation findings, the potential root cause is traced to user error.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 depuy synthes 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 (b)(6), and no non-conformance was identified.

• Brand Name: 4K EPSCP SCP,4.0,30,167,MITEK
• 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: elba bello ; 325 paramount drive; raynham, MA ; 9083863534
• MDR Report Key: 23631802
• Report Number: 1221934-2025-04511
• Device Sequence Number: 13084005
• Product Code: HRX
• UDI-Device Identifier: 10886705031993
• UDI-Public: (01)10886705031993
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/24/2025

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: 242137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 12/29/2025; 02/05/2026; 04/02/2026; 04/03/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/05/2026; 02/05/2026; 04/02/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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