MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. CUP FORCEPS 7844T5L30 DIA4MM BIOPSY; PFM11

Catalog Number 7844T5L30

Device Problem Failure to Cut (2587)

Patient Problem Laceration(s) (1946)

Event Date 12/16/2021

Event Type  Injury  

Event Description

A facility reported that during the use of biopsy cup forceps (7844t5l30), the jaw of the forceps did not cut.A tear of the patient¿s piriform sinus mucous membrane occurred.The staff changed the device to complete the biopsy.The event resulted in a biopsy of limited numbers.It was reported that the patient did not have any pain or inflammation as a result.There was no consequence to the patient; an x-ray was performed, and no abnormality was noted.There was no increase in surgery time; however, there was a 24-hour extension of hospitalization for the patient.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

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

A facility reported that during the use of biopsy cup forceps (7844t5l30), the jaw of the forceps did not cut.A tear of the patient¿s piriform sinus mucous membrane occurred.The staff changed the device to complete the biopsy.The event resulted in a biopsy of limited numbers.It was reported that the patient did not have any pain or inflammation as a result.There was no consequence to the patient; an x-ray was performed, and no abnormality was noted.There was no increase in surgery time; however, there was a 24-hour extension of hospitalization for the patient.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10.The cup biopsy forceps (7844t5l30) were returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the cup biopsy forceps verified the complaint reported by the customer as valid.The device doesn't cut properly.Root cause analysis: the cup biopsy forceps were never returned for servicing prior to this reported event.Considering the date of manufacture and the absence of servicing, the reported event was due to a normal wear of the device.

Event Description

N/a.

• Brand Name: CUP FORCEPS 7844T5L30 DIA4MM BIOPSY
• 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13405863
• MDR Text Key: 285931882
• Report Number: 3003249645-2022-00001
• Device Sequence Number: 1
• Product Code: GEN
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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: 7844T5L30
• Device Lot Number: 1925181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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