FDA Adverse Event
Malfunction
Summary report: N
LL100 MULTI TIP W/TC
MDR report key: 11503460
·
Received March 17, 2021
Report
- Report Number
- 1216677-2021-00023
- Event Type
- Malfunction
- Date Received
- March 17, 2021
- Date of Event
- October 30, 2020
- Report Date
- March 4, 2021
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- GEH
- PMA / PMN Number
- K813024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COOPER SURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.
Description of Event or Problem · 1
CUSTOMER STATED "INTERMITTENT TC". REPAIR TECH STATED "CONFIRMED - TEMP READING OF HARNESS ONLY - THERMOCOUPLE HARNESS WIRE WAS NEVER CONNECTED TO INLET TUBE THERMOCOUPLE WIRE". REFERENCE REPAIR ORDER #(B)(4). REFERENCE REPAIR TECH COMMUNICATIONS FOR CLARIFICATIONS. LL100 MULTI TIP W-TC 900629 E-COMPLAINT-(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403497 | LL100 MULTI TIP W/TC | LL100 MULTI TIP W/TC | GEH | COOPERSURGICAL, INC. | 900629 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |