FDA Adverse Event
Malfunction
Summary report: N
INTERPULSE HANDPIECE WITH HIGH FLOW TIP
MDR report key: 2082604
·
Received April 27, 2011
Report
- Report Number
- 2648666-2011-00118
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 31, 2011
- Manufacturer
- STRYKER INSTRUMENTS PUERTO RICO
- Product Code
- FQH
- PMA / PMN Number
- K972069
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TWO DEVICES WERE RETURNED TO THE MFR FOR EVAL. NO LOT NUMBER WAS PROVIDED FOR EITHER DEVICE. ACCORDING TO THE QUALITY INVESTIGATION, ONE BATTERY ON EACH UNIT WAS BELOW THE VOLTAGE REQUIREMENTS AND FOUND TO BE CORRODED AND LEAKING INSIDE THE BATTERY PACK.
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO INTERPULSE HANDPIECES WERE LEAKING FROM THE BATTERY PACKS. THE DEVICES WERE ATTEMPTED TO BE USED DURING A PROCEDURE, BUT NOTHING ENTERED THE SURGICAL SITE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERPULSE HANDPIECE WITH HIGH FLOW TIP | FQH | STRYKER INSTRUMENTS PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |