MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for COVIDIEN LF4418C manufactured by Medline Renewal.
[139076409]
It was reported that a thin metal spring was found inside the patient during a liver retraction procedure. The reporting facility was unsure if the spring came from the reprocessed device (ligasure impact, sealer/divider nano-coated, compatible with ft10 generator 18cm) or if the spring was left in the patient from a procedure years prior. The spring was reportedly successfully retrieved from the patient through an unidentified method. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The device was returned for evaluation and this device had been reprocessed by medline renewal. The device was inspected and no damage was found. Lf4418c devices do not have small springs matching the one found in the patient. The source of the spring could not be confirmed. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139076410]
It was reported that a thin metal spring was found inside the patient during a liver retraction procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2019-00001 |
| MDR Report Key | 8409882 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-11 |
| 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 IMPACT, SEALER/DIVIDER NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 18CM |
| Product Code | NUJ |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-02-27 |
| Catalog Number | LF4418C |
| Lot Number | 390958 |
| 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. Required No Informationntervention | 2019-03-11 |