RESCUE
Report
- Report Number
- 3005099803-2024-01850
- Event Type
- Malfunction
- Date Received
- April 22, 2024
- Date of Event
- April 1, 2024
- Report Date
- July 22, 2024
- Manufacturer
- ANREI MEDICAL
- Product Code
- OCZ
- UDI-DI
- 26948318968613
- PMA / PMN Number
- K101298
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE: A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.
REPORT NUMBER 3005099803-2024-01850 WAS SUBMITTED IN ERROR. BOSTON SCIENTIFIC CORPORATION DOES NOT HAVE A REGULATORY/CONTRACTUAL OBLIGATION TO REPORT FOR THE RESCUE DEVICE. THE MANUFACTURER, ANREI MEDICAL, HAS THE REGULATORY/CONTRACTUAL OBLIGATION TO REPORT. B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. IMDRF DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOX OF THE RESCUE RETRIEVAL FORCEPS WAS RECEIVED AND UNPACKED ON AN UNKNOWN DATE. DURING UNPACKING, THE SEAL OF THE PRODUCT POUCH WAS PEELED OFF AND THE BOX WAS FLATTENED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVED DURING THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOX OF THE RESCUE RETRIEVAL FORCEPS WAS RECEIVED AND UNPACKED ON AN UNKNOWN DATE. DURING UNPACKING, THE SEAL OF THE PRODUCT POUCH WAS PEELED OFF AND THE BOX WAS FLATTENED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVED DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2389410 | RESCUE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | ANREI MEDICAL | M00527451 | 2023080901 | 26948318968613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |