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U.S. Department of Health and Human Services

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

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INTEGRA MICROFRANCE S.A.S. CUP FORCEPS 7844T5L30 DIA4MM BIOPSY; PFM11 Back to Search Results
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.
 
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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 Key13405863
MDR Text Key285931882
Report Number3003249645-2022-00001
Device Sequence Number1
Product Code GEN
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Number7844T5L30
Device Lot Number1925181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/07/2022
Initial Date FDA Received01/31/2022
Supplement Dates Manufacturer Received03/02/2022
Supplement Dates FDA Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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