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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PIRANHA; FORCEPS, BIOPSY, NON-ELECTRIC
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BOSTON SCIENTIFIC CORPORATION PIRANHA; FORCEPS, BIOPSY, NON-ELECTRIC Back to Search Results
Model Number M0065051600
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2023
Event Type  malfunction  
Manufacturer Narrative
E: this event was reported by bsc sales rep.The initial reporter facility name is: (b)(6) hospital.H6: imdrf device code a051104 captures the reportable event of jaws failed to closed.
 
Event Description
It was reported to boston scientific corporation that a piranha was used in a biopsy procedure performed on an unknown date.During the procedure, the jaws were opened but unable to close.There was no patient complication as a result of this event.
 
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Brand Name
PIRANHA
Type of Device
FORCEPS, BIOPSY, NON-ELECTRIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key17207874
MDR Text Key317958200
Report Number3005099803-2023-03354
Device Sequence Number1
Product Code FCL
UDI-Device Identifier08714729302599
UDI-Public08714729302599
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0065051600
Device Catalogue Number505-160
Device Lot Number0029081910
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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