MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SLIDE LOCK HUNTER BOWEL GRASPER 5MM 45CM; GRASPING FORCEPS

Catalog Number	610165
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 5mm 45cm slide lock hunter bowel grasper (610165) was missing the screw that secures it to the laryngoscope.Additionally, a portion of the instrument broke off inside the patient during laparoscopic general surgery.At this time, it is unknown whether the broken part was retrieved.No further patient consequence was reported.
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.
Additional Manufacturer Narrative
Updated fields: d4 (product lot number), d9, g3, g6, h2, h3, h6, h11.Additional information: there was no delay in surgery; the component that controls the mechanism was lost, and a replacement was used to complete the procedure.There is no negative information concerning the patient's recovery.The 610165 slide lock hunter bowel grasper 5mm 45cm was returned for evaluation: failure analysis: the returned 610165 slide lock hunter bowel grasper is in used condition with wear along the shaft and on the handles.The set screw in the jaws was missing, leaving the jaws loose and unusable, and staining was visible on the jaws.The product lot indicates a manufacturing date of 2019.Damage to the screw may be the result of wear over multiple years of use.Per the product information for use (ifu) jl-00016," the instrument must be inspected to assure proper functioning prior to each use with particular attention paid to the condition of all moving parts, tips, box locks, ratchets, and cutting edges." the set screw broke off due to wear.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis: the reported complaint is confirmed.The returned 610165 slide lock grasper is in used condition with damage along the shaft and handles, as well as a missing set screw due to wear.

• Brand Name: SLIDE LOCK HUNTER BOWEL GRASPER 5MM 45CM
• Common Device Name: GRASPING FORCEPS
• 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: 22376357
• Report Number: 3014334038-2025-00088
• Device Sequence Number: 4437270
• Product Code: GCJ
• UDI-Device Identifier: 10381780146780
• UDI-Public: 10381780146780
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 07/17/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 610165
• Device Lot Number: AG1910
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown