FDA Adverse Event
Injury
Summary report: N
MINI LAP INSTRUMENTS
MDR report key: 1474424
·
Received September 10, 2009
Report
- Report Number
- 3007123990-2009-00001
- Event Type
- Injury
- Date Received
- September 10, 2009
- Date of Event
- September 25, 2007
- Report Date
- October 29, 2007
- Manufacturer
- MINI LAP TECHNOLOGIES INC.
- Product Code
- KOG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
IT IS BELIEVED THAT THE DOCTOR FORCEFULLY RETRACTED THE HANDLE BEYOND THE SAFETY INTERLOCK POSITION RESULTING IN DAMAGE TO THE DEVICE AND EXPOSING THE NEEDLE PORTION OF THE INSTRUMENT. THIS LEFT THE NEEDLE EXPOSED AND THEREFORE INADVERTENTLY PUNCTURED THE GALL BLADDER.
Description of Event or Problem · 1
DURING A CHOLECYSTECTOMY PROCEDURE, THE GALLBLADDER WAS PUNCTURED WITH THE TIP OF THE NEEDLE OF THE MINI LAP INSTRUMENT. THE GALL BLADDER WAS GOING TO BE REMOVED AS PART OF THE SURGERY ANYWAY. THERE WERE NO COMPLICATIONS TO THE PT AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINI LAP INSTRUMENTS | ENDOSCOPIC INSTRUMENTS | KOG | MINI LAP TECHNOLOGIES INC. | 0255000001 | ML000040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |