FDA Adverse Event
Malfunction
Summary report: N
VISISTAT 35R 6/BOX
MDR report key: 14842864
·
Received June 28, 2022
Report
- Report Number
- 3003898360-2022-00269
- Event Type
- Malfunction
- Date Received
- June 28, 2022
- Date of Event
- June 24, 2022
- Report Date
- June 24, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- QQS
- UDI-DI
- 14026704631770
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.
Description of Event or Problem · 0
AFTER 4 STAPLES FIRED, THE STAPLER JAMMED AND NO MORE STAPLES COULD BE FIRED. THERE WAS NO CONSEQUENCE FOR THE PATIENT. ANOTHER DEVICE WAS USED TO SOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2044311 | VISISTAT 35R 6/BOX | STAPLE, REMOVABLE (SKIN) | QQS | TELEFLEX MEDICAL | IPN028492 | 73B2200424 | 14026704631770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |