FDA Adverse Event
Malfunction
Summary report: N
EXTRACTION KIT
MDR report key: 18544111
·
Received January 19, 2024
Report
- Report Number
- 3005099803-2024-00072
- Event Type
- Malfunction
- Date Received
- January 19, 2024
- Date of Event
- December 18, 2023
- Report Date
- January 19, 2024
- Manufacturer
- PRINCE MEDICAL
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF MATERIAL DEFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOLINE VIPER WAS USED IN AN EXPLANTATION PROCEDURE OF AN ORBERA BALLOON ON (B)(6) 2023. DURING THE PROCEDURE, ONE FLANGE OF THE FORCEPS BENT AND STAYED OUTSIDE THE SHEATH. THE BENT FLANGE WAS GRABBING TISSUE AS IT WAS BEING PULLED OUT THE ESOPHAGUS. THE PATIENT EXPERIENCED MINOR BLEEDING AND PAIN. THERE WAS NO REPORTED TREATMENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1211027 | EXTRACTION KIT | RETRACTOR | GAD | PRINCE MEDICAL | AS2290718 | 0000021818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |