MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SLIDE LOCK TENACULUM FORCEPS 5MM 32CM; GRASPING FORCEPS

Catalog Number	605152
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
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
The following was reported via mdr report number mw5154082: "at approximately 0855 during a laparoscopic hysterectomy dr.Inserted a 5mm laparoscopic tenaculum through a 5mm port into the patient's inflated abdomen.Upon opening the jaws of the tenaculum, the instrument spontaneously broke leaving a screw inside the patient's abdomen.The jaws of the tenaculum were then stuck open inside the abdomen without the ability to remove safely through the port, trapping the instrument inside the body.Dr.Was able to remove the instrument by simultaneously removing the port and instrument together.The screw was retrieved successfully by dr.And placed in the needle counter on the surgical field by the cst.Or manager, was informed of the incident.Manager responded to or7 to evaluate the instrument.Sterile processing department director, was also made aware of the incident.Surgery continued by doctors end of report.A postoperative x-ray was completed.The instrument was sequestered and the item recovered was placed in a specimen cup.This was also referred to quality.A note was placed by the surgeon and the surgeon disclosed this information to the patient." it was subsequently reported that during a laparoscopic procedure, the pin connecting two tenaculum graspers came off and fell into the patient.All parts were recovered.There was no consequence to the patient and no surgical delay occurred.
Additional Manufacturer Narrative
Updated fields: d4 (udi#).The slide lock tenaculum forceps 5mm 32cm (605152) was returned for evaluation: failure analysis: the slide lock tenaculum forceps (605152) was returned in used condition with wear and staining on the surface.Evaluation shows one of the set screws at the jaw was broken off.Root cause analysis: the reported complaint was confirmed.The product lot number indicates a manufacture date prior to 2014.Damage to the screw may be the result of environmental damage or wear over ten years of use.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h10, h11.

• Brand Name: SLIDE LOCK TENACULUM FORCEPS 5MM 32CM
• 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: 19464427
• Report Number: 3014334038-2024-00113
• Device Sequence Number: 20696048
• Product Code: GCJ
• UDI-Device Identifier: 10381780146650
• UDI-Public: 10381780146650
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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: 605152
• Device Lot Number: 1143045
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 10/09/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/01/2024; 10/10/2024
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female