FDA Adverse Event
Injury
Summary report: N
MAKO BIOPSY FORCEPS
MDR report key: 6047879
·
Received October 21, 2016
Report
- Report Number
- 3007591333-2016-00053
- Event Type
- Injury
- Date Received
- October 21, 2016
- Date of Event
- September 22, 2016
- Report Date
- October 12, 2016
- Manufacturer
- ENDOCHOICE, INC.
- Product Code
- FCL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FORCEPS WERE RETURNED AND ON INSPECTION A REASON FOR THE EVENT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE FORCEPS RIPPED AND TORE THE MUCOSA. THEY WERE ALSO DIFFICULT TO PULL BACK THROUGH THE WORKING CHANNEL. THERE WAS NO FURTHER PATIENT INJURY OR OTHER ADVERSE HEALTH CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700379 | MAKO BIOPSY FORCEPS | FORCEPS, BIOPSY, NON-ELECTRIC | FCL | ENDOCHOICE, INC. | DBC-206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |