MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for SMOKE EVAC. PENCIL, PB, COATED SHK-VS-CL manufactured by Lina Medical Aps.
[186731289]
A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186731290]
It was reported that there was a potential sterility breach on the packaging of the device. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00793 |
| MDR Report Key | 9897615 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-30 |
| 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 | MRS. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMOKE EVAC. PENCIL, PB, COATED |
| Generic Name | ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES |
| Product Code | GEI |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-26 |
| Catalog Number | SHK-VS-CL |
| Lot Number | 1919041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 GLOSTRUP DK-2600 DK DK-2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |