MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-17 for LIGASURE IMPACT LF4318 manufactured by Covidien Lp.
[34572587]
(b)(4). Date of initial report: 12/17/2015. The complaint sample was not returned for evaluation. A review of the relevant device history records for this lot found no pertinent entries and that it was released after meeting all product specifications. No trend has been associated with this issue. Without a return of the product, this complaint cannot be investigated further and is unconfirmed at this time. If additional information is obtained, or the sample is returned, we will re-open this investigation.
Patient Sequence No: 1, Text Type: N, H10
[34572588]
The customer reported that during a procedure involving the bladder, the device handle would not open after use. Another device was used without issue to continue the procedure. No patient injury occurred and no medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00928 |
| MDR Report Key | 5308452 |
| Date Received | 2015-12-17 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-12-08 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2015-04-30 |
| Date Added to Maude | 2015-12-17 |
| 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 | MS. SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN LP |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGASURE IMPACT LF4318 |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-12-17 |
| Model Number | LF4318 |
| Catalog Number | LF4318 |
| Lot Number | 51070023X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-17 |