MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[32227266]
(b)(4). Date of initial report : (b)(6) 2015. To date the incident sample has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[32227267]
The customer reported that during a total laparoscopic hysterectomy bleeding was observed at the broad, uterine and ovarian ligaments where the device had been used. End tones, indicating a complete seal cycle, were provided by the generator in use. A new device of the same type was opened and used to successfully complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[38092356]
(b)(4). One used lf5544 was received for evaluation. Examination of the returned sample could not confirm the reported issue. The device was tested and multiple seals were made on porcine tissue of various sizes. All seal cycles were completed satisfactorily and end tones heard indicating completed activation cycles. The investigation found the device to function normally and within specifications. Review of the device history records for this product found no potentially contributing entries. There are environmental factors during use that can affect seal quality, and the instructions-for-use included with this product lists tissue sealing recommendations and cautions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00842 |
| MDR Report Key | 5246115 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 2015-06-29 |
| Date Added to Maude | 2015-11-24 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGASURE ADVANCE PISTOL GRIP |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-24 |
| Returned To Mfg | 2015-12-14 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 51490024X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-11-24 |