MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. JOHANN FENESTRATED JAWS INSERT, 20 X 5MM JAWS; PFM16

Catalog Number CEV625P1U

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Perforation (2668)

Event Date 05/11/2022

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

It was reported that the johann fenestrated jaws insert (cev625p1u) of the forceps were too aggressive and led to several wounds of the small intestine during its mobilization (gastric bypass).The medical staff needed to do two stitches (sutures) on the small intestine at the lesions/wounds.The event led to an increase in surgery time of 10 minutes.No complications occurred thereafter.

Manufacturer Narrative

This is 1 of 2 reports for the component of the forceps reportedly used during this event and is linked to mfg report number 3003249645-2022-00034.The johann fenestrated jaws insert (cev625p1u) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the returned johann fenestrated jaws insert was unable to conclusively verify the complaint reported by the customer as valid; therefore, an investigation for cause was unable to be performed.The received device was compliant with the specifications.The setting of tightening was compliant and there was no traumatic part on the jaws which can explain the reported event.The investigation did not highlight any defect.It was concluded that this complaint is unrelated to this device and unconfirmed.At present, we consider this complaint to be closed.

• Brand Name: JOHANN FENESTRATED JAWS INSERT, 20 X 5MM JAWS
• 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: 15103528
• MDR Text Key: 296583523
• Report Number: 3003249645-2022-00033
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• 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,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CEV625P1U
• Device Lot Number: 5989218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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