MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. AFORCEPS MCL19 LEFT BOUCHAYER HEART; PFM11

Catalog Number MCL19

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned and evaluated.The reported issue was confirmed.A dhr review was performed and no anomalies related to the associated complaint were found.The device manufactured prior to november 2005 and no maintenance was performed by integra (b)(4) service and repair during that time.The age of the instrument and the lack of maintenance can reasonably conclude that this event was not attributable to integra¿s product.As the instrument is over 22 years old, we can conclude the jaw weakened with years of use and lack of maintenance.

Event Description

It was reported that during a laryngoscopy with biopsy, the jaw of the forceps broke and the broken part fell inside the mouth of the patient.The event led to an increase of surgery time of 1.5 ¿ 2 hours.A fibro-optic bronchoscopy was used for aspiration of the broken part.The broken part was located in the right primary bronchus.Another device was available and used to complete the surgery.The patient was monitored in inpatient for two days under bronchial surveillance with aerosol and x-ray.

• Brand Name: AFORCEPS MCL19 LEFT BOUCHAYER HEART
• 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: 7402344
• MDR Text Key: 104542671
• Report Number: 2523190-2018-00050
• Device Sequence Number: 1
• Product Code: MMO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2018

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: MCL19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR