MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for LF1212A REP125881 manufactured by Medline Renewal.
[128324205]
It was reported that a small spring from the broken hand piece button of the reprocessed covidien ligasure? Small jaw fell into patient during a lymph node biopsy. The physician reportedly was able to locate the broken piece and successfully retrieved it from the patient through an unknown method. There was no serious injury or follow-up care reported related to the event. Due to the reported incident, medline renewal is filing this medwatch report. The sample was not available to be returned for evaluation. A review of the reprocessing records was performed and 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 information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[128324206]
It was reported that a small spring from the broken hand piece button of the reprocessed covidien ligasure? Small jaw fell into patient during a lymph node biopsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2018-00012 |
| MDR Report Key | 8054947 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-22 |
| Date Added to Maude | 2018-11-09 |
| 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 |
| Generic Name | COVIDIEN LIGASURE? SMALL JAW INSTRUMENT |
| Product Code | NUJ |
| Date Received | 2018-11-09 |
| Model Number | LF1212A |
| Catalog Number | REP125881 |
| Lot Number | 392836 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
| Generic Name | COVIDIEN LIGASURE? SMALL JAW INSTRUMENT |
| Product Code | NUJ |
| Date Received | 2018-11-09 |
| Model Number | LF1212A |
| Catalog Number | REP125881 |
| Lot Number | 392836 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2018-11-09 |