FDA Adverse Event
Injury
Summary report: N
RAT TOOTH FORCEPS
MDR report key: 2202139
·
Received August 5, 2011
Report
- Report Number
- 1825146-2011-00031
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 8, 2011
- Report Date
- August 4, 2011
- Manufacturer
- COOK UROLOGICAL, INC.
- Product Code
- FAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY RETURNED RAT TOOTH FORCEPS INDICATING THEY WOULD NOT GRASP AND REMOVE THE STENT. THE FORCEPS HAVE NOT BEEN THOROUGHLY INVESTIGATED AT THIS TIME. THE DEVICE RETURNED WAS NOTED TO FUNCTION PROPERLY WHEN GRASPING AN OBJECT, HOWEVER, WHEN AN OBJECT WAS GRASPED IT DID NOT HAVE A FIRM GRIP. ADD'L INFO HAS BEEN REQUESTED AND UPON COMPLETION OF THE INVESTIGATION A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
THE PHYSICIAN TRIED TO REMOVE A STENT AND THE GRASPERS KEPT COMING OFF THE STENT. THE GRASPERS WOULD NOT GRAB THE STENT AND REMOVE IT. THE PHYSICIAN HAD TO TAKE THE PT TO THE OPERATING ROOM TO REMOVE THE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAT TOOTH FORCEPS | FAD STENT, URETERAL | FAD | COOK UROLOGICAL, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |