MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SLIDE LOCK FUNDUS GRASPING FORCEPS DA 5MM 37CM; N/A

Catalog Number	610107DA
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the tip of the slide lock fundus grasping forceps da 5mm 37cm (610107da) broke in the patient.The grasper tip reportedly broke and bent during a laparoscopic procedure.Another instrument was used to complete the procedure.An x-ray was performed and the results were negative for any foreign body.It was reported that the patient's condition was stable following the event and no significant delay in procedure occurred.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The slide lock fundus grasping forceps (610107da) was returned for evaluation.The device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.Failure analysis - visual inspection of the slide lock fundus grasping forceps noted that the device was returned in used condition with the pin broken out due to rough handling or environmental damage.The pin was returned, and no pieces appeared to be missing.Root cause - the reported complaint was confirmed.The product was returned to the supplier for further evaluation.

• Brand Name: SLIDE LOCK FUNDUS GRASPING FORCEPS DA 5MM 37CM
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21222460
• Report Number: 3014334038-2025-00004
• Device Sequence Number: 19699683
• Product Code: GCJ
• UDI-Device Identifier: 10381780146698
• UDI-Public: 10381780146698
• Combination Product (Y/N): N
• PMA/510(K) Number: K931928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 610107DA
• Device Lot Number: 2244344
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 139 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White