MAUDE Adverse Event Report: MEDLINE RENEWAL; COVIDIEN LIGASURE¿ SMALL JAW INSTRUMENT

Model Number LF1212A

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Type of Device: COVIDIEN LIGASURE¿ SMALL JAW INSTRUMENT
• 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: 8054947
• MDR Text Key: 128324205
• Report Number: 3032391-2018-00012
• Device Sequence Number: 0
• Product Code: NUJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: LF1212A
• Device Catalogue Number: REP125881
• Device Lot Number: 392836
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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