MAUDE Adverse Event Report: MEDLINE RENEWAL COVIDIEN; LIGASURE IMPACT, SEALER/DIVIDER NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 18CM

Catalog Number LF4418C

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that a thin metal spring was found inside the patient during a liver retraction procedure.

• Brand Name: COVIDIEN
• Type of Device: LIGASURE IMPACT, SEALER/DIVIDER NANO-COATED, COMPATIBLE WITH FT10 GENERATOR 18CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8409882
• MDR Text Key: 139076409
• Report Number: 3032391-2019-00001
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: LF4418C
• Device Lot Number: 390958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR