MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. BIPOLAR FORCEPS MCO290 70MM W/TRAY; PFM11

Catalog Number MCO290

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 2523190-2018-00064.

Event Description

This report is 2 of 2.The integra sales representative reported on behalf of the customer that on an unknown date, a mco290 bipolar forceps mco290 70 mm w/tray was unable to effectively cauterize during an endoscopic sinus surgery.The instrument was used in two office procedures but the surgeon was not able to effectively cauterize with this instrument, the patients had to be taken to the operating room (or).Additional information has been requested but no other clinical information has been provided.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.The failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.The device history record reviewed and no anomalies that could be associated with the complaint were observed.The active part of the instrument is crooked.This consequence may be due to a shock, a fall or a too violent use.Indeed, this instrument is very sensitive.No manufacturing defects were noted.

• Brand Name: BIPOLAR FORCEPS MCO290 70MM W/TRAY
• Type of Device: PFM11
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7462133
• MDR Text Key: 106585399
• Report Number: 2523190-2018-00063
• 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,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: MCO290
• Device Lot Number: 2401194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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; Required Intervention