MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-11-30 for MARYLAND JAW LAP (37CM) LF1737 manufactured by Covidien Lp.
[32291800]
(b)(4). The incident sample has been requested but to date 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
[32291801]
The customer reported that during surgery on a living donor kidney, sealing was not completed even though an end tone, indicating a completed seal cycle was heard. The vessel appeared to be sealed but opened later during the procedure. Patient experienced blood loss of approximately 500ccc's but no transfusion was required. No other patient injury or tissue damage was reported. Procedure was completed without further complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00852 |
| MDR Report Key | 5254255 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-11-24 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | BOULDER |
| 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 | 2015-11-30 |
| Model Number | LF1737 |
| Catalog Number | LF1737 |
| Lot Number | NOT KNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2015-11-30 |