FDA Adverse Event
Malfunction
Summary report: N
ENDOLINE PUNC DEFLATION NEEDLE
MDR report key: 20709111
·
Received November 15, 2024
Report
- Report Number
- MW5162609
- Event Type
- Malfunction
- Date Received
- November 15, 2024
- Date of Event
- November 12, 2024
- Report Date
- November 13, 2024
- Manufacturer
- PRINCE MEDICAL SAS
- Product Code
- LTI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ENDOSCOPIST STUCK WITH THE ORBERA DEFLATION NEEDLE UPON REMOVAL OF GASTRIC BALLOON. THIS DEVICE IS IMPOSSIBLE TO UNHOOK ONCE IT GRABS SOMETHING INSIDE OF PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2610232 | ENDOLINE PUNC DEFLATION NEEDLE | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | PRINCE MEDICAL SAS | SN4000718 | 40326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |