FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS
MDR report key: 221527
·
Received April 28, 1999
Report
- Report Number
- 1527736-1999-02536
- Event Type
- Malfunction
- Date Received
- April 28, 1999
- Date of Event
- April 2, 1999
- Report Date
- April 2, 1999
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (4) DEVICES WERE USED DURING A VIDEO ASSISTED THORACIC SURGERY. IT WAS REPORTED BY THE AFFILIATE THAT AFTER FIRING THE 1ST INSTRUMENT, THE FIRED STAPLES MALFORMED AND THE ANVIL DISLODGED. A SECOND DEVICE WAS USED TO CONTINUE THE CASE. AFTER THE FOURTH FIRING OF THE 2ND DEVICE, THE ANVIL DISLODGED. THE CASE WAS COMPLETED WITH A NEW INSTRUMENT. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS | LINEAR CUTTERS - ENDOSCOPIC | KOG | ETHICON ENDO-SURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |