FDA Adverse Event
Malfunction
Summary report: N
SURGIWAND II 5MM W/CAUT/L-HOOK/TUBE/GFS
MDR report key: 2150478
·
Received June 16, 2011
Report
- Report Number
- 2647580-2011-00424
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 6, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- HET
- PMA / PMN Number
- K903207
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING PREPARATION FOR SURGERY, IT WAS NOTICED THAT THE TIP OF THE DEVICE WAS CRACKED. THE DEVICE WAS NOT USED FOR A PATIENT. ANOTHER DEVICE WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGIWAND II 5MM W/CAUT/L-HOOK/TUBE/GFS | SINGLE USE LAPAROSCOPIC HAND INSTRUMENT | HET | USSC PUERTO RICO | P0M1440L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |