FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** DEXTRUS* SEAL CAP
MDR report key: 3190283
·
Received June 26, 2013
Report
- Report Number
- 3005075853-2013-03285
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 19, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GCJ
- PMA / PMN Number
- K070198
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HALS COLOSTOMY REVERSAL PROCEDURE, A BLUE PORTION OF THE CAP EXPLODED. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED AS USUAL. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291097 | ENDOPATH** DEXTRUS* SEAL CAP | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | J4C735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |