MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-12 for NEW LIGASURE 5MM LF1537 manufactured by Covidien Lp.
[36051175]
(b)(4). 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
[36051176]
The customer reported that during the procedure, the device jaws could not be re-opened. The surgeon manually opened the jaws and reported that the handle joint was broken. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[40426525]
(b)(4). One used lf1537 device was received for evaluation. Visual inspection and testing of the device confirmed that the latch was closed and would not open. The device was also found to have signs of harsh use or abrasive cleaning methods, including bleached white jaws. Further inspection confirmed that the latch within the device is broken, causing the handle to lock instead of open. A review of the device history records for this item found no potentially contributing entries, and no trend is associated with this issue. The investigation identified the likely root cause as misuse by the customer, where rough use or harsh cleaning methods contributed to device breakage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00032 |
| MDR Report Key | 5360515 |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-23 |
| Date of Event | 2015-12-23 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2015-02-20 |
| Date Added to Maude | 2016-01-12 |
| 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 | NEW LIGASURE 5MM |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-01-12 |
| Returned To Mfg | 2016-02-08 |
| Model Number | LF1537 |
| Catalog Number | LF1537 |
| Lot Number | 50160221X |
| 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 | 2016-01-12 |