FDA Adverse Event
Injury
Summary report: N
HS SYNERGY COMBO HOOK BLADE
MDR report key: 1912788
·
Received December 2, 2010
Report
- Report Number
- 3005075853-2010-06787
- Event Type
- Injury
- Date Received
- December 2, 2010
- Date of Event
- November 10, 2010
- Report Date
- May 17, 2024
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PEDIATRIC TONSILLECTOMY PROCEDURE, SEVERAL BURNS WERE NOTICED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE INSIDE OF THE CHEEK WHERE THE SHAFT OF THE DEVICE TOUCHED WAS RED AND STARTING TO RAISE, AND THE BASE OF THE TONGUE HAD A SPOT WHERE THE SKIN WAS STARTING TO SLOUGH OFF. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS SYNERGY COMBO HOOK BLADE | BLADE | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | GENERATOR AND HANDPIECE| GENERATOR AND HANDPIECE |