FDA Adverse Event
Summary report: N
LINEAR CUTTER
MDR report key: 1783131
·
Received July 30, 2010
Report
- Report Number
- MW5016925
- Date Received
- July 30, 2010
- Date of Event
- July 14, 2010
- Report Date
- July 22, 2010
- Manufacturer
- ETHICON
- Product Code
- GDW
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ETHICON LINEAR CUTTER 75MM (RER-NTLC75, LOT# G4T106) WAS USED FOR LARYNGECTOMY, BUT ABOUT 0.5CM OF THE PART OF SPECIMEN WAS NOT CUT DUE TO HANDLE OF THE CUTTER WAS BROKEN. REP STATED THE SURGEON DID NOT UNDERSTAND THAT THE TURNING DEVICE COULD NOT BE RETURNED TO ORIGINAL SIDE. STAPLER WOULD NOT ALLOW STAPLES TO GO FORWARD AS A SAFETY AS IT THINKS IT HAS BEEN DEPLOYED. DIAGNOSIS OR REASON FOR USE: SURGICAL STAPLING/CUTTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAR CUTTER | NONE | GDW | ETHICON | NTLC75 | G4T106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |