MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for COVIDIEN LF1212ACR manufactured by Medline Renewal.
[128324961]
It was reported that three reprocessed ligasure? Small jaw instrument lf1212ac tissue sealers error-out during an unidentified parathyroid procedure. The reported devices reportedly would not complete hemostasis. Per report, the surgical procedure time was extended and patient required additional anesthesia medication. General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. Another device was opened and the procedure was successfully completed. There was no serious injury reported related to this event. Due to the reported incident and in an abundance of caution, this medwatch is being filed. Two of the three devices that failed were returned for evaluation. The reported complaint is confirmed through functional testing. Review of the device history record indicated that all processes were conducted as required. A root cause could not be determined at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[128324962]
It was reported that the reprocessed covidien ligasure? Small jaw instrument tissue sealer error out during use and total procedure time was extended. The patient received additional anesthesia medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2018-00017 |
| MDR Report Key | 8089244 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2018-11-20 |
| 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 | STEPHEN WILSON |
| Manufacturer Street | 1500 NE HEMLOCK AVE |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal | 97756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COVIDIEN |
| Generic Name | LIGASURE? SMALL JAW INSTRUMENT (PURPLE/WHITE) COMPATIBLE WITH FT10 GENERATOR 18. |
| Product Code | NUJ |
| Date Received | 2018-11-20 |
| Returned To Mfg | 2018-11-07 |
| Catalog Number | LF1212ACR |
| Lot Number | 393460 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-20 |