FDA Adverse Event
Malfunction
Summary report: N
5MM X 32CM STRYKERPROBE J-TIP
MDR report key: 1894206
·
Received November 2, 2010
Report
- Report Number
- 2936485-2010-00811
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 14, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CASE, THE DOCTOR ATTEMPTED TO RETRACT THE TIP OF THE UNIT INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE TIP OF THE UNIT BECAME STUCK INSIDE THE SHEATH, AS IT MAY HAVE BEEN BENT AND BECAME LODGED ON THE EDGE OF THE SHEATH. THE SHEATH CRACKED AND A PORTION OF IT FELL INTO THE PATIENT. THE DOCTOR ATTEMPTED TO LOCATE THE BROKEN PIECE INSIDE THE ABDOMEN OF THE PATIENT AND A NURSE ATTEMPTED TO USE STRAINERS ON THE IRRIGATION FLUID TO TRY AND LOCATE THE BROKEN PIECE INSIDE A SUCTION CANISTER. THE BROKEN PIECE COULD NOT BE LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM X 32CM STRYKERPROBE J-TIP | CAUTERY | GCJ | STRYKER ENDOSCOPY SAN JOSE | 8E24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |