FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS MED ACCESS RETRACTOR
MDR report key: 3100341
·
Received May 8, 2013
Report
- Report Number
- 3005075853-2013-02172
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 12, 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
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HALS COLECTOMY PROCEDURE THE SEAL BROKE. OR. STAFF OPENED ANOTHER TO COMPLETE SURGERY. NO PATIENT CONSEQUENCES REPORTED. DEVICES WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201154 | DEXTRUS MED ACCESS RETRACTOR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |