MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV225 DIA 5MM 350MM MONOPOLAR; PFM16

Catalog Number CEV225

Device Problem Peeled/Delaminated (1454)

Patient Problem Unspecified Gastrointestinal Problem (4491)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 2 reports for 2nd device from the same facility, different event date and linked to mfg report number 2523190-2021-00089: a facility reported that during laparoscopic cholecystectomy, the coating on the hook cev225 became stuck between the patient's gallbladder and liver, which resulted in an unspecified injury to the patient.The surgeon removed the plastic parts stuck in patient, and another device was used to complete the procedure.The event led to increased surgery time, but not precise for how long.

Manufacturer Narrative

The hook cev225 was returned for evaluation: device history record (dhr): the dhr has been reviewed and no anomalies that could be associated with the complaint were observed.Failure analysis: the evaluation verified the complaint as valid.The coating is melted at the tip of the device; the other parts of the coating are not damaged.A test of coagulation has been performed but the reported issue was not reproduced.No manufacturing defect was found.Root cause: the investigation did not highlight any manufacturing defect.The reported event may be due to a contact with a another instrument or the use of a too important voltage.

• Brand Name: HOOK CEV225 DIA 5MM 350MM MONOPOLAR
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 11798693
• MDR Text Key: 249749550
• Report Number: 2523190-2021-00090
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1