FDA Adverse Event
Injury
Summary report: N
RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN
MDR report key: 3973293
·
Received August 1, 2014
Report
- Report Number
- 1923569-2014-00014
- Event Type
- Injury
- Date Received
- August 1, 2014
- Date of Event
- July 7, 2014
- Report Date
- August 1, 2014
- Manufacturer
- CAREFUSION
- Product Code
- HAO
- PMA / PMN Number
- EXEMPT
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT AVAILABLE. IF THE DEVICE SHOULD BECOME AVAILABLE, A FOLLOW-UP EMDR WILL BE SUBMITTED.
Description of Event or Problem · 1
BROKEN EMAIL RECEIVED (B)(6) 2014 FROM CAREFUSION'S LEGAL DEPARTMENT. IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THE INSTRUMENT BROKE DURING WRIST SURGERY. PER THE REPORT "THE PATIENT SUSTAINED INJURIES AS A RESULT OF A DEFECTIVE V MUELLER ARTHROSCOPIC PROB, SERIAL NO. (B)(4) WHICH BROKE DURING SURGERY (B)(6) 2012 AT THE (B)(6) , RESULTING IN A RETAINED FOREIGN BODY WHICH REQUIRED SURGICAL REMOVAL. THE PATIENT HAD TO UNDERGO A SECOND SURGERY (B)(6) 2013 IN ORDER TO REMOVE THE FOREIGN BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450853 | RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN | INSTRUMENT, SURGICAL, NON-POWERED | HAO | CAREFUSION | NL3785-16 | J04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |