MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-10 for VISISTAT 35R 6/BOX 528135 manufactured by Teleflex Medical.
[182743986]
(b)(4). The device history review for the product visistat 35r 6/box lot #73b1900439 investigation did not show issues related to the complaint. The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[182743987]
It was reported that the fired staples were not properly formed. A new unit was used instead to complete the procedure in the end, however, the same issue occurred to 18 staplers in total.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00253 |
| MDR Report Key | 9811004 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-02-18 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISISTAT 35R 6/BOX |
| Generic Name | STAPLE, REMOVABLE (SKIN) |
| Product Code | GDT |
| Date Received | 2020-03-10 |
| Catalog Number | 528135 |
| Lot Number | 73B1900439 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |