MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TUBE CEV649-5B DIA 5MM 350MM; PFM16

Catalog Number CEV649-5B

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 8 of 8 for tube (cev649-5b), which is linked to mfg report numbers: 2523190-2021-00212, 2523190-2021-00211, 2523190-2021-00213, 2523190-2021-00214, 2523190-2021-00215, 2523190-2021-00216, and 2523190-2021-00217.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.The customer returned 12 device components, as it is unknown which device was used in this event.We are awaiting further information.

Manufacturer Narrative

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 tube (cev649-5b) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure was observed.Evaluation of the tube was unable to conclusively verify the complaint as valid.Therefore, an investigation for cause was unable to be performed.During evaluation, it was observed that the tube was bent and there were scratches on the sheath.It passed the electrical test.These defects are not in relation with the reported event.According to the customer, the device injured the patient when it was in contact with the small intestine.However, the tube is not in contact with the small intestine.Root cause analysis: the investigation did not highlight any defect in relation with the reported event.Thus, this complaint is unconfirmed.The defects on the device are due to a bad handling during the storage or the reprocessing.

• Brand Name: TUBE CEV649-5B DIA 5MM 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: 12602695
• MDR Text Key: 275882567
• Report Number: 2523190-2021-00218
• 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: 10/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV649-5B
• Device Lot Number: 3477764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1