MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for NEW LIGASURE 5MM LF1537 manufactured by Covidien Lp.
[39006732]
(b)(4). The sample has been requested but 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
[39006733]
The customer reported that the jaws of the device would no longer open. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[45241873]
(b)(4). Date of initial report: (b)(6) 2016. Date of follow-up report: (b)(6) 2016. One used lf1537 was received for evaluation, and examination of the returned device could not confirm the reported issue of difficulty opening. The device was not latched shut when received and the jaws would open normally. However, an alternative issue was identified where the device could not be latched shut. Further examination found this to be due to broken components within the handle. The ski guide appears to have caught on the internal track and the tabs, breaking the tabs that lock the latch. Investigation of this issue could not reliably determine the cause of the event. Review of the device history records for this lot shows no potentially contributing factors, and that it was released after meeting all quality specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00151 |
| MDR Report Key | 5444844 |
| Date Received | 2016-02-18 |
| Date of Report | 2016-01-26 |
| Date Mfgr Received | 2016-05-02 |
| Device Manufacturer Date | 2015-02-20 |
| Date Added to Maude | 2016-02-18 |
| 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 | 3 |
| Brand Name | NEW LIGASURE 5MM |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-02-18 |
| Returned To Mfg | 2016-03-30 |
| Model Number | LF1537 |
| Catalog Number | LF1537 |
| Lot Number | 50160223X |
| 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 | 2016-02-18 |