FDA Adverse Event
Malfunction
Summary report: N
PIRANHA
MDR report key: 16706602
·
Received April 10, 2023
Report
- Report Number
- 3005099803-2023-01872
- Event Type
- Malfunction
- Date Received
- April 10, 2023
- Date of Event
- March 21, 2023
- Report Date
- April 10, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FCL
- UDI-DI
- 08714729302599
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF THE DEVICE WAS NOT CLOSING APPROPRIATELY.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PIRANHA WAS USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE DEVICE WAS NOT CLOSING APPROPRIATELY. THE PROCEDURE WAS CANCELED BECAUSE THE HOSPITAL DID NOT HAVE ANOTHER BIOPSY FORCEPS. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549791 | PIRANHA | FORCEPS, BIOPSY, NON-ELECTRIC | FCL | BOSTON SCIENTIFIC CORPORATION | M0065051600 | 0028111906 | 08714729302599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |