FDA Adverse Event
Malfunction
Summary report: N
SPIDER - SURGICAL FLEX MONOPOLAR HOOK
MDR report key: 1759417
·
Received June 24, 2010
Report
- Report Number
- 3007593944-2010-00002
- Event Type
- Malfunction
- Date Received
- June 24, 2010
- Date of Event
- May 24, 2010
- Report Date
- June 24, 2010
- Manufacturer
- TRANSENTERIX, INC.
- Product Code
- GCJ
- PMA / PMN Number
- K091697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON REPORTED EXCESSIVE CHARRING AT THE MONOPOLAR HOOK TIP. THE DEVICE WAS REMOVED NUMEROUS TIMES DURING THE PROCEDURE FOR CLEANING. INFO FROM THE CASE ALSO INDICATED THAT THE MONOPOLAR HOOK TIP CAME INTO CONTACT WITH OTHER METAL INSTRUMENTS. THE SURGEON NOTED SPARKING NEAR THE HOOK TIP AND REPLACED THE DEVICE WITH A NEW UNIT TO FINISH THE PROCEDURE. NO INJURY OR IMPACT TO THE PT WAS REPORTED. UPON RETURN FOR COMPLAINT EVALUATION, VISUAL INSPECTION SHOWED INSULATION BREAKDOWN AT THE DEVICE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDER - SURGICAL FLEX MONOPOLAR HOOK | GCJ | TRANSENTERIX, INC. | 9000031 | DSC043201001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |