MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for LIGASURE BLUNT TIP OPEN SEALER/DIVIDER LF1520 manufactured by Covidien Lp.
[32407416]
(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
[32407417]
The customer reported that during a hysterectomy, the device jaws could not be re-opened. A new instrument of the same type was opened and used to complete the case. There was no patient injury or tissue damage.
Patient Sequence No: 1, Text Type: D, B5
[38297188]
(b)(4). The reported condition was confirmed. The jaws were locked closed when received and the trigger was jammed. Excessive eschar was found between the jaws. The ski guide was caught on the internal track due to lateral force placed on the latch causing it to jump the a-track. The latch would not release to open the jaws. The device was disassembled and the investigation discovered damage to the ski tabs where the ski caught on the a-track. This occurs when the user applies excessive force to the latch. Manufacturing non-conformances were reviewed. No entries pertinent to the customer's report were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00855 |
| MDR Report Key | 5255071 |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2015-12-31 |
| Device Manufacturer Date | 2015-03-04 |
| Date Added to Maude | 2015-11-30 |
| 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 | 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 BLUNT TIP OPEN SEALER/DIVIDER |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-30 |
| Returned To Mfg | 2015-11-09 |
| Model Number | LF1520 |
| Catalog Number | LF1520 |
| Lot Number | 50160238X |
| 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 | 2015-11-30 |