MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for MARYLAND JAW LAP (37CM) LF1737 manufactured by Covidien Lp.
[37243816]
(b)(4). The incident device has been received and is under evaluation. When the device evaluation is complete a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[37243817]
The customer stated the knife blade became stuck in the middle of the jaws during the procedure. The surgeon did not notice this and went to grasp tissue. Bleeding of less than 200cc occurred as a result. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[44188308]
(b)(4). One used lf1737 was received for evaluation. The reported condition of the knife blade being stuck and exposed was confirmed. The knife did not move smoothly when the latch and trigger were retracted. The blade did not return to its home position properly. The device was disassembled and investigation found the red wire was caught along the pull tube slider and restricted the movement of the blade due to a supplier issue. Engineering was notified of the customer? S report. 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 | 1717344-2016-00097 |
| MDR Report Key | 5397444 |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-08 |
| Date of Event | 2016-01-07 |
| Date Mfgr Received | 2016-03-22 |
| Device Manufacturer Date | 2015-10-08 |
| Date Added to Maude | 2016-01-28 |
| 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 | MARYLAND JAW LAP (37CM) |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-01-28 |
| Returned To Mfg | 2016-01-28 |
| Model Number | LF1737 |
| Catalog Number | LF1737 |
| Lot Number | 52610155X |
| 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 | 2016-01-28 |