MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TUBE CEV649-5B DIA 5MM 350MM; MICROFRANCE INSTRUMENTS

Catalog Number	CEV649-5B
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1of 3 reports and is related to mfg number 3003249645-2026-00007: a facility reported that a burn occurred on a patient during a laparoscopic repair of abdominal wall hernia associated with an umbilical hernia, with mesh placement, involving the tube cev649-5b dia 5mm 350mm (cev649-5b).The patient sustained a superficial burn, which has resulted in a small burn scar.The healthcare facility provided local care and monitoring of the patient, and the medical device was quarantined.There was no report of an increase in surgical time.
Additional Manufacturer Narrative
The tube cev649-5b dia 5mm 350mm (cev649-5b) was returned for an evaluation.The device history record (dhr) could not be reviewed because no data was available corresponding to the year of manufacture, 2009.Failure analysis: the investigation findings noted that the complaint concerns the assembly of three parts: the cev10395r handle, batch 09-03, manufactured in 2003 (b)(4); the cev649-5b tube, batch 091102 (b)(4), manufactured in 2009; and the cev625-1 insert, batch 11-04 (b)(4), manufactured in 2004.These three instruments are old.The tube was repaired by an external service provider.During this repair, the metal surface was matted, whereas our internal process normally involves brushing.To prevent any damage to the markings during the repair, the service provider covered them; this practice does not meet integra standards.Upon its return, the tube underwent our electrical testing and passed the test.The handle shows no damage; it was repaired by an external provider because it bears a non-imf marking.The insert exhibited some twisting, but this is unrelated to the initial reported issue and does not affect the current claim.Root cause analysis: despite their age, the instruments showed no damage related to the user's reported problem.Inspections revealed no anomalies that could have contributed to the reported incident.Since the instruments were not directly implicated, the burn was caused by user error: the instrument was powered on during handling, and the metal part of the tube came into contact with the patient's abdomen, resulting in the observed burn.The insert exhibits slight twisting: this deformation is consistent with the mechanical stresses that can occur during cleaning cycles or when stored in contact with other instruments.No correlation was found between this twisting and the initial problem reported in the complaint.Integra microfrance (imf) recommends repairs within its factory and cannot guarantee the services provided by an external service provider.

• Brand Name: TUBE CEV649-5B DIA 5MM 350MM
• Common Device Name: MICROFRANCE INSTRUMENTS
• 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: 24661775
• Report Number: 3003249645-2026-00006
• Device Sequence Number: 9198280
• Product Code: GEI
• UDI-Device Identifier: 10381780094876
• UDI-Public: 10381780094876
• 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
• Report Date (Section B): 03/23/2026

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: CEV649-5B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• 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
• Patient Sex: Unknown