FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1852287
·
Received October 4, 2010
Report
- Report Number
- 3005075853-2010-05666
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- August 27, 2010
- Report Date
- September 17, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME - (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). ADDED ADDITIONAL INFORMATION THE DEVICE WAS RETURNED WITH THE TISSUE PAD DETACHED FROM THE CLAMP ARM, BUT RETURNED WITH THE DEVICE. THE DEVICE WAS TESTED WITH A TEST HANDPIECE AND GENERATOR AND THE DEVICE DID ACTIVATE. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER FUNCTIONALLY TESTING COULD NOT BE PERFORMED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE CLEANING THE BLADE THE WHITE TISSUE PAD CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |