MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for COVIDIEN LF1212A manufactured by Medline Renewal.
[145770930]
It was reported that during an unspecified parathyroid procedure, two reprocessed covidien ligasure? Small jaw instruments would not seal properly. Reportedly, this extended the procedure for 45 minutes requiring additional anesthesia for the patient. The procedure was successfully finished and there was no effect on the patient's status/stability as a result of this incident. Due to the reported extension of the procedure time and need for additional anesthesia, this medwatch is being filed. The devices were returned for evaluation. The medline renewal packaging, where lot information is printed, were not returned. Upon visual and functional inspection of the returned devices, the reported issue was confirmed and a corrective action was initiated. The root cause was corrosion of the ceramic isolation dots, found on the sealing part of the devices. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145770931]
It was reported that two reprocessed covidien ligasure? Small jaw instrument would not seal properly during a parathyroid procedure resulting in patient requiring additional anesthesia due to a 45-minute extension of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2019-00004 |
| MDR Report Key | 8465123 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-03-29 |
| 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 | LF1212A |
| Product Code | NUJ |
| Date Received | 2019-03-29 |
| Returned To Mfg | 2019-03-21 |
| Catalog Number | LF1212A |
| Lot Number | UNK |
| 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 | 2019-03-29 |