MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LS3112
Medical Device Problem Codes	Detachment Of Device Component (1104); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, the device had an insulation issue wherein the grey rubber peeled off.They opened new device to complete the procedure.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary one device was received for evaluation.This device had not been used in the treatment or diagnosis of the patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.Visual inspection found the primary wire insulation to be visible through part of the gray rubber strain relief.No bare wire was exposed.The package was unopened.The reported condition was not confirmed.The investigation found gray insulation did not completely cover the underlying insulated wires due to a short shot during the molding process.This anomaly will not affect the functioning of the device.The device functioned normally and there is no concern for patient safety.The missing gray insulation is not considered a defect.The manufacturing instructions and verification procedures define exposed metal and cut or damaged primary wire insulation as a defect.Primary wire insulation exposed through the flex relief without exposing the bare wire is not considered a defect.The device passed hipot testing around the exposed primary insulation indicating no electrical leakage.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7341796
• Report Number: 1717344-2018-00354
• Device Sequence Number: 18868133
• Product Code: GEI
• UDI-Device Identifier: 10884524002514
• UDI-Public: 10884524002514
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 249576X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1