MAUDE Adverse Event Report: MEDLINE RENEWAL COVIDIEN; LIGASURE¿ SMALL JAW INSTRUMENT (PURPLE/WHITE) COMPATIBLE WITH FT10 GENERATOR 18.

Catalog Number LF1212ACRH

Device Problem Overheating of Device (1437)

Patient Problem Tissue Damage (2104)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that during a mastectomy, the reprocessed ligasure¿ small jaw instrument (purple/white), compatible with ft10 generator 18.8 cm, became "too hot" and the tissue was "compromised".Despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.Due to the reported "compromised" tissue, this medwatch is being filed.The sample was returned for evaluation and the complaint could not be confirmed.No excessive thermal spread was observed during functional testing.A review of the device history record was performed and this indicated that all processes were conducted as required at the time the lot was processed.A definitive root cause for the reported issue 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 during a mastectomy, the reprocessed covidien ligasure¿ small jaw instrument got "too hot" resulting in tissue being "compromised.".

• Brand Name: COVIDIEN
• Type of Device: LIGASURE¿ SMALL JAW INSTRUMENT (PURPLE/WHITE) COMPATIBLE WITH FT10 GENERATOR 18.
• 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: 9290776
• MDR Text Key: 190749970
• Report Number: 3032391-2019-00025
• 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: Other
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: LF1212ACRH
• Device Lot Number: 418524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other