MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; PFM16

Catalog Number	CEV2295A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
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
This report is 2 of 2, for the 2nd 380mm dia5mm hook handle (cev229b) reportedly used during this event and is related to mfg#: 3003249645-2024-00052.It was reported that "during a hysterectomy, the hook melted".This happened twice.It was reported that no part detached from the hook.There was no impact to the patient, as they could complete the surgery with a third hook.Surgery time was increased by five (5) minutes.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
Corrected b5 of initial report: this report is 2 of 2, for the 2nd hook for hook handle cev2295a) reportedly used during this event and is related to mfg# 3003249645-2024-00052.
Additional Manufacturer Narrative
Updated fields: d4 (primary udi#), g3, g6, h2, h3, h6, h11.The 3pk n5 hook for hook handle (cev2295a) was returned for evaluation: evaluation of the hook for hook handle could not verify the complaint reported by the customer as valid.According to the customer the hook melted, but after observation it was determined that the device was only slightly abraded by cleaning.The customer likely cleaned the instrument with an agent that was too abrasive.
Event or Problem Description
N/a.

• Brand Name: HOOK CEV2295A 3PK N5 FOR HOOK HANDLE
• Common Device Name: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20500220
• Report Number: 3003249645-2024-00053
• Device Sequence Number: 17950881
• Product Code: GEI
• UDI-Device Identifier: 10381780092551
• UDI-Public: 10381780092551
• Combination Product (Y/N): N
• PMA/510(K) Number: K210942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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: CEV2295A
• Device Lot Number: 6764638
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 11/18/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HOOK HANDLE CEV229B
• Patient Sex: Unknown