MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-14 for LIGASURE ATLAS HANDSWITCHING 20CM LS1020 manufactured by Covidien Lp.
[36344091]
(b)(4). Date of initial report: 01/14/2016. 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
[36344092]
The customer reported that during a procedure, the device would not open after activation. The customer also reported that the sealing tone was heard, but the device did not seal the tissue. The jaws were opened forcibly and another device was used to complete the procedure. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[38713978]
(b)(4). Date of initial report: (b)(6) 2016. Date of follow-up report: (b)(6) 2016. One used ls1020 ligasure device was received for evaluation. Visual inspection of the returned device found a staple wedged within the jaws, preventing the jaws from closing and sealing properly. When the staple was removed, the device functioned normally and within specifications. The device was activated on porcine tissue, and multiple seals on vessels of various sizes were made. All seals were within specifications and end tones heard each time indicating completed cycles. Review of the device history records for this lot found no potentially contributing entries, and no trend is associated with this complaint. This issue is attributed to mishandling by the user, where the device was used to seal tissue that contained a staple. The ifu included with this product warns users not to attempt to seal over clips or staples.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00012 |
| MDR Report Key | 5368048 |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-24 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2016-01-14 |
| 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 LLC (SHANGHAI) |
| Manufacturer Street | BLDG.10, 789 PUXING RD. |
| Manufacturer City | SHANGHAI 20 1114 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 20 1114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGASURE ATLAS HANDSWITCHING 20CM |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-01-14 |
| Returned To Mfg | 2016-01-21 |
| Model Number | LS1020 |
| Catalog Number | LS1020 |
| Lot Number | S5E0012X |
| 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 | 2016-01-14 |