FDA Adverse Event
Malfunction
Summary report: N
INTUITIVE SURGICAL
MDR report key: 14075797
·
Received April 11, 2022
Report
- Report Number
- 3012811961-2022-00003
- Event Type
- Malfunction
- Date Received
- April 11, 2022
- Date of Event
- March 2, 2022
- Report Date
- April 11, 2022
- Manufacturer
- ECOLAB/MICROTEK MEDICAL INC.
- Product Code
- PUI
- UDI-DI
- 50748426117265
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A TEAR IN THE EQUIPMENT DRAPE BESIDE THE CANNULA SEAL. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1581126 | INTUITIVE SURGICAL | INSTRUMENT ARM DRAPE | PUI | ECOLAB/MICROTEK MEDICAL INC. | NA | D192737A | 50748426117265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |