MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCISSORS CEV394B 3,5MM 360MM STR; PFM16

Catalog Number	CEV394B
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/18/2025
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
A facility reported that during a laparoscopic hernia procedure, with the scissors cev394b 3.5mm 360mm str (cev394b), there was a "possible conductivity problem with the scissor, and the user had electrical shock." it was reported that the user felt an electrical shock on his thumb.Although the device was in contact with the patient, they were not injured, and a five-minute surgical increase was reported; however, the surgery was completed using another device.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11 corrected field: g4: pma/510(k) #.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected fields: b2, h1.Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The scissors cev394b 3,5mm 360mm str (cev394b) was returned for evaluation: failure analysis: investigational findings found no damage on the instrument that could explain such an incident.The electrical safety test was performed and found to be compliant.Other damages were noted, unrelated to the reported issue: the sheath of the tube shows visible marks, the blades exhibit signs of friction and scratches, the movable blade was damaged at a specific point along its edge, and this last defect prevents the scissors from cutting properly.Root cause analysis: it is highly probable that the user was wearing damaged gloves, which allowed electrical current to pass through.The safety warnings and usage precautions outlined in ifu nt060 and addendum nt119 a were either not followed or only partially adhered to.Additional observations-marks and scratches observed on the sheath and blades are consistent with repeated use and cleaning over time.The instrument is 16 years old and has never been returned to integra-microfrance (imf) after-sales service for repair.This wear was considered normal.The damage to the movable blade likely resulted from cutting a material that was too hard and not suitable for the instrument¿s intended use.Electrosurgical instruments are designed for tissue removal and/or bleeding control.

• Brand Name: SCISSORS CEV394B 3,5MM 360MM STR
• 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: 23062983
• Report Number: 3003249645-2025-00038
• Device Sequence Number: 9987361
• Product Code: GEI
• UDI-Device Identifier: 10381780092834
• UDI-Public: 10381780092834
• Combination Product (Y/N): N
• PMA/510(K) Number: K993655
• 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): 10/24/2025

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: CEV394B
• Device Lot Number: 091201
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 10/24/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2009
• 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: BIPOLAR FORCEPS CEV397BG 320MM GAYET (CEV397BG).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown