MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PUNCTURE NEEDLE W/IRRIG 32CM; SUCTION/IRRIGATION

Catalog Number	600490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The puncture needle w/irrig 32cm (600490) was not returned to the manufacturer after three good faith effort (gfe) attempts to retrieve the product; therefore, an evaluation of the device could not be performed.The provided sales order number shows a sale date of may 2022.Damage may be the result of wear over two years of use.However, a definitive root cause cannot be determined.
Event or Problem Description
A facility reported that during a laparoscopic procedure, the tip of the laparoscopic aspiration needle/puncture needle w/irrig 32cm (600490) broke off.It was subsequently reported that "the needle broke off while inside the patient, then needed to be retrieved and then removed laparoscopically by the surgeon." all broken parts were recovered.It was reported that there was no delay in the procedure.No patient injury was reported.

• Brand Name: PUNCTURE NEEDLE W/IRRIG 32CM
• Common Device Name: SUCTION/IRRIGATION
• 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: 21258012
• Report Number: 3014334038-2025-00013
• Device Sequence Number: 15463464
• Product Code: GCJ
• UDI-Device Identifier: 10381780152255
• UDI-Public: 10381780152255
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 600490
• Device Lot Number: AY2111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 11/01/2021
• 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