MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD L-SHAPE HOOK ELECTRODE 5MM32CM; ELECTROSURGICAL COAGULATION

Catalog Number 600318

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

A facility reported that during a laparoscopic abdominal procedure, the tip of l-shape hook electrode 5mm32cm (600318) broke off into the surgical site.The broken piece was removed with a laparoscopic grasper.The surgical team verified all pieces were removed and contained.It was reported that a replacement device was available foe use.There was no consequence to the patient; however, it is unknown whether a surgical delay occurred.The following information was subsequently reported via medsun 1600580000-2023-8009: "the surgeon was using the reusable l hook inside the patient during a laparoscopic procedure.As he was using the l hook, the tip broke off into the patient.The tip was able to be recovered and was removed from the patient." orginal intended procedure: laparoscopic abdominal procedure.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The l-shape hook electrode 5mm32cm (600318) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: the l-shape hook electrode was received in used condition with wear on the insulation and its tip broken off.The tip was returned with the instrument.Root cause analysis: the reported complaint was confirmed.The product was sold in january 2022.This damage may be the result of rough handling or wear/environmental damage over a year of use.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

N/a.

• Brand Name: L-SHAPE HOOK ELECTRODE 5MM32CM
• Type of Device: ELECTROSURGICAL COAGULATION
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17101623
• MDR Text Key: 317750973
• Report Number: 3014334038-2023-00093
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K932456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600318
• Device Lot Number: AB2107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female