MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV134 BIPOLAR 350MM MOUIEL; PFM16

Catalog Number CEV134

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2015

Event Type  Injury  

Event Description

Customer initially reports that the device stopped working during a bariatric surgery.The patient has a hematoma.The patient was treated with surgicel and hematoma drainage.The surgeon finished the surgery by using the forceps in monopolar mode on (b)(6) 2015.No further information available.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

On (b)(6) 2015, integra investigation completed.Method, failure analysis, device history evaluation results: failure analysis - the instrument was not returned.The investigation could not be done.Device history evaluation - unknown lot number impossible to do the dhr review.Conclusion: it is impossible to confirm the complaint and to find the root cause.

• Brand Name: FORCEPS CEV134 BIPOLAR 350MM MOUIEL
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 4788050
• MDR Text Key: 5817605
• Report Number: 2523190-2015-00024
• Device Sequence Number: 0
• Product Code: HIN
• Reporter Country Code: FR
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other