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.
[36066966]
(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
[36066967]
The customer reported that the device jaws were difficult to re-open while being used during a cystectomy. The device was replaced with another device of the same type to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[43901070]
(b)(4). Date of follow-up report: 04/28/2016. 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
[43901071]
In addition to the previously submitted issue, inspection of the received device found that a metal flange on the device jaws is missing and was not returned. The user facility has confirmed that the piece did not disengage during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[45373597]
(b)(4). Date of follow-up report: 04/28/2016. Date of second follow-up: 05/17/2016. One used lf1537 device was received for evaluation. Visual inspection of the returned device found the metal flange that pulls the inner tube to open the device was broken, preventing operation of the jaws. The pull tube cam slot was bent and broken as well. These components are made of stainless steel and should not break in the way observed without exerting excessive and unusual force on the device. Checks in place during manufacturing would have detected these issues before release. Review of the device history records for this product shows no potentially contributing factors, and no trend is associated with this complaint. The root cause of this issue is due to rough and unusual use, or possible multiple uses by the customer. The ifu warns that this product is designed as a single use device; subjecting the product to reprocessing or multiple uses could potentially impact the structure and components of the device. The ifu also cautions users not to use the device if damaged.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00030 |
| MDR Report Key | 5360441 |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-21 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2013-08-09 |
| 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 | 2016-03-30 |
| Model Number | LF1537 |
| Catalog Number | LF1537 |
| Lot Number | 254754X |
| Device Expiration Date | 2018-08-18 |
| 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 |