FDA Adverse Event
Malfunction
Summary report: N
VERSAPOINT
MDR report key: 1993310
·
Received January 21, 2011
Report
- Report Number
- 2210968-2011-00068
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- June 23, 2010
- Report Date
- December 22, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- HIH
- PMA / PMN Number
- K040302
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT AN ELECTROSURGICAL PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE ELECTRODE STOPPED CUTTING. UPON INSPECTION, THE SURGEON NOTED THAT THE TIP OF THE ELECTRODE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSAPOINT | ELECTRODE | HIH | ETHICON, INC. | NA | 4691001074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |