MAUDE Adverse Event Report: Medos International SÃ rl HD LAPSCP,EP,5.5,30,300; Laparoscope, General & Plastic Surgery

Catalog Number	242633
Medical Device Problem Codes	Material Fragmentation (1261); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the hd lapscp,ep,5.5,30,300 device was chipped/shaved/delaminate.It was noted by the reporter that the device was scratched.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2026.All available information has been disclosed.
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: investigation summary the product was returned to depuy synthes service center for evaluation then, the device was forwarded to oem and the following defects were identified: repair level 3 major repair - other damages caused by customer - outer tube damaged, needle outer tube bent - outer tube damaged, distal tip distal tip damaged deep scratches/knicks keel loose/raised keel sunken - illumination distal tip fiber damaged - optical system, optical components broken lenses in optical system distal cover glass/negative damaged - cosmetic issue scratches/dents rust/discoloration visual : scratched/nicked, broken (2+ pieces) : chipped/shaved/delaminated, visual : deformed/bent and visual : corrosion/rusting/pitting the defective parts needs to be replaced to resolve the issues.The reported complaint was confirmed based on the service evaluation results.The investigation traced the potential cause to user error.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.

• Brand Name: HD LAPSCP,EP,5.5,30,300
• Common Device Name: Laparoscope, General & Plastic Surgery
• 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 02767 ; +1(908)386-3534
• MDR Report Key: 50846282
• Report Number: 1221934-2026-04259
• Device Sequence Number: 10050503
• Product Code: GCJ
• UDI-Device Identifier: 10886705030194
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K941541
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 242633
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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