FDA Adverse Event
Injury
Summary report: N
SURGICAL BLADE IN CRANIOTOMY PACK
MDR report key: 4249970
·
Received November 7, 2014
Report
- Report Number
- 1423395-2014-00029
- Event Type
- Injury
- Date Received
- November 7, 2014
- Date of Event
- October 1, 2014
- Report Date
- October 31, 2014
- Manufacturer
- ASPEN SURGICAL
- Product Code
- LRO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT HAS BEEN REPORTED THAT TWO BLADES BROKE DURING A CRANIOTOMY PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THE BLADES BROKE UPON INITIATION OF AN INCISION. THE BLADES WERE NOT RETURNED FOR EVALUATION. WE HAVE NOT BEEN MADE AWARE OF ANY SERIOUS INJURY OR NEED FOR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THESE BLADES ARE A COMPONENT IN A CUSTOM SURGICAL PACK. THEY ARE BARD-PARKER STAINLESS STEEL BLADES FROM ASPEN SURGICAL PRODUCTS. ASPEN HAS BEEN NOTIFIED OF THE INCIDENT AND AS THE MANUFACTURER OF THE DEVICE, THEY WILL MAKE THE DETERMINATION IF ANY CORRECTIVE ACTION IS REQUIRED.
Description of Event or Problem · 1
THE BLADE BROKE DURING A PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719322 | SURGICAL BLADE IN CRANIOTOMY PACK | LRO | ASPEN SURGICAL | 14FD2730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |