MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS MCL19BIS RIGHT BOUCHAYER HEART; PFM11

Catalog Number MCL19BIS

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

The device was not 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.

Event Description

It was reported that on (b)(6) 2018 during an laryngomicroscopy with twinstream and co2 laser operation, while trying to ¿catch¿ the removing tissue, it was noticed under the microscope that half of the forceps were defective.The device, forceps mcl19b is right bouchayer heart had been used before and it was ¿unbroken¿.The forceps were placed in water and wiped clean with gauze.The instrument table, gauze and floor were examined to try and locate the missing part.The surgeon also checked the operating area and performed fiber bronchoscopy to check the patient¿s lungs.The part was not found.There was minor harm reported and extra work that occurred during the operation.Request for additional information has been sent.Additional information was received on 17dec2018 stating that the patient was a (b)(6) woman, who had an increase time of 10 ¿ 15 minutes during her operation.An x-ray was performed the next day and no foreign object was detected.It is unknown if there was any underlying medical condition and if the patient had any symptoms/consequences due to the un-found broken part.

Event Description

N/a.

Manufacturer Narrative

Product was returned and the evaluation verified the complaint as valid.The mobile jaw is broken.The fragment was not returned.An observation of the breakage area did not reveal any manufacturing or material defect.Considering that no material or manufacturing defect was found and the date of manufacture of the device, the most probable cause of this rupture is the recurrence of impacts on the instrument during its use or its reprocessing, which weakened the jaw and led to the reported event.

• Brand Name: FORCEPS MCL19BIS RIGHT 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
• MDR Report Key: 8181612
• MDR Text Key: 130990972
• Report Number: 2523190-2018-00178
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCL19BIS
• Device Lot Number: 121002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWINSTREAM
• Patient Age: 57 YR