N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9690989
- MDR report key
- 9690989
- Report number
- 9612501-2020-00247
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-01
- Date received
- 2020-02-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ENDO STITCH | ENDOSCOPIC TISSUE APPROXIMATION DEVICE | DAVIS & GECK CARIBE LTD | OCW | 173016 | 173016 | J9H18535Y | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-10 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE NEEDLE GOT STUCK IN THE INSTRUMENT. THE INSTRUMENT WAS NOT ATTACHED TO ANY PART OF THE PATIENT WHEN THIS HAPPENED. THE SURGEON REMOVED THE INSTRUMENT FROM THE PATIENT AND ATTEMPTED TO MANUALLY REMOVE THE SUTURE. AT THIS TIME, THE NEEDLE BROKE. PORTION OF THE NEEDLE STILL ATTACHED TO INSTRUMENT.