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 Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: damages caused by customer.- outer tube damaged, needle.Outer tube dent{s).- outer tube damaged, distal tip.Distal tip damaged.Keel loose/raised.- illumination.Distal tip fiber damaged.- particulate, optics.Particulate under distal lens.Particulate in system.- optical system, optical components.Prism loose.Broken lenses in optical system.- cosmetic issue.Scratches/dents.Rust/discoloration.Visual: deformed/bent, visual: scratched/nicked and broken (b)(4) pieces: chipped/shaved/delaminated.Per service report, this complaint was confirmed.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, and no non-conformance was identified.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the hd lapscp,ep,5.5,30,300 device was broken (2+ pieces) : chipped/shaved/delaminated.It was reported in the service order that the device had an unknown issue.It was unknown when the event occurred.There were no reports of delays to a surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2026.All available information has been disclosed.

• 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): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24984412
• Report Number: 1221934-2026-01664
• Device Sequence Number: 9698986
• Product Code: GCJ
• UDI-Device Identifier: 10886705030194
• UDI-Public: (01)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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2017
• 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