MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HANDLE CEV6185R DIA 5MM STR W/RATCHET; PFM16

Catalog Number CEV6185R

Device Problem Break (1069)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The dia 5mm str handle w/ratchet (cev6185r) was not returned for evaluation; therefore, an investigation for cause was unable to be performed.Device history record (dhr) was not reviewed as lot number information has not been provided.According to the complaint description, the surgeon was burned during the surgery.The cause of this event cannot be determined with absolute certainty.It could come from tube insulation defect or a contact during coagulation between the metallic part of the instrument and the hand of the surgeon through porous gloves, at the same time than a contact with the monopolar plaque through the patient (or through the operating table, if the patient is not isolated from it).No corrective actions is required at this time.In 2016 and 2017, as part of a corrective and preventive action, new non-monopolar handles without plug and associated modular references have been created.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

This report is 3 of 3 for the dia 5mm str handle w/ratchet (cev6185r) component of the forceps used during this event, and is linked to mfg numbers: 3003249645-2024-00011, 3003249645-2024-00015.It was reported that during laparoscopy, the surgeon was burned three times on the fingers while using forceps (coagulation on).The sheath of the forceps was damaged.The device was in contact with a patient; however, no patient injury occurred.The event reportedly led to a 10-minute increase in surgery time.It was later reported that the surgeon did not change the instrument during the procedure between each burn.The burns appeared before the surgeon removed the forceps.When the devices/components were checked in the sterilization department, only the tube was identified as defective.

• Brand Name: HANDLE CEV6185R DIA 5MM STR W/RATCHET
• Type of Device: 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 ; 6099362319
• MDR Report Key: 18823141
• MDR Text Key: 336732518
• Report Number: 3003249645-2024-00016
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV6185R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• 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