MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. INSERT CEV625-1 FENESTRATED 350MM; PFM16

Catalog Number CEV625-1

Device Problem Electrical Shorting (2926)

Patient Problems Hemorrhage/Bleeding (1888); Bowel Perforation (2668); Unspecified Gastrointestinal Problem (4491)

Event Date 09/07/2021

Event Type  Injury  

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 Description

This report is 2 of 8 for insert (cev625-1), which is linked to mfg report numbers: 2523190-2021-00212, 2523190-2021-00213, 2523190-2021-00214, 2523190-2021-00215, 2523190-2021-00216, 2523190-2021-00217, and 2523190-2021-00218.A facility reported that the forcep (with components tube, insert and handle) injured a patient when it came in contact with the small intestine.The event led to an unspecified increase of surgery time.No further information has been provided.Customer returned 12 device components, as it is unknown which device was used in this event.We are awaiting further information.

Manufacturer Narrative

Corrected fields: h6 (clinical code).Additional information was received on 11-october-2021: during bypass surgery, the four laparoscopy forceps injured the patient as soon as they were in contact with him.They led to some bleeding during the use on small intestine and one of them pierced the small intestine.The increase of surgery time was more than 30 minutes.No information was provided on the status of the patient now.The insert (cev625-1) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure was observed.Failure analysis: the evaluation of the insert was unable to conclusively verify the complaint as valid.Therefore, an investigation for cause was unable to be performed.The insert was bent.The jaws were compliant, there was no burrs or sharpened part which can explain the reported event.The reported event is not related to this device.On (b)(6) 2021, a call was made to the customer to inform them that there was no traumatic part on the device.According to the operating room nurse, it was a "difficult" patient.Root cause: the investigation did not highlight any defect in relation with the reported event.It may be due to the sensitivity of the patient.The insert was probably bent during the reprocessing or the storage.

Event Description

N/a.

• Brand Name: INSERT CEV625-1 FENESTRATED 350MM
• 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: 12602691
• MDR Text Key: 277756798
• Report Number: 2523190-2021-00211
• 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: 10/28/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV625-1
• Device Lot Number: 3498753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/10/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1