N
Patient 1
THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
MAUDE MDR 6544520
- MDR report key
- 6544520
- Report number
- 2027111-2017-01764
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-04-19
- Date received
- 2017-05-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- WENDY KOBAYASHI
- Address
- 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CNO12, GELPOINT PATH 9CM | FER | APPLIED MEDICAL RESOURCES | FER | 10 | 10 | 1253551 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-04 | 0 |
Event Narratives#
D
Patient 1
TRANSANAL MASS INCISION - THE SEAL FROM THE GELPOINT TROCAR SLEEVE WAS DISLODGED TOWARDS THE END OF THE CASE. A STORZ NEEDLE DRIVER AND VLOCK SUTURE WERE USED WITHIN THE SLEEVE. IT WAS STATED THAT THE INSTRUMENTS WERE PASSED THROUGH THE SLEEVE NO MORE THAN 10 TIMES AND THE MANIPULATION OF THE INSTRUMENTS WERE NOT CONSIDERED AGGRESSIVE. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE WITH NO PATIENT INJURY. TYPE OF INTERVENTION - NA. PATIENT STATUS - NO PATIENT INJURY.