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

Model Number LF1937

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.Visual inspection found the device's cam pin was disengaged from the jaw.The disengaged cam pin was not returned.The reported condition was confirmed.The investigation found the device jaw was misaligned due to the broken cam pin weld.The broken weld cause the cam pin to become disengaged which cause the jaw failure.The investigation identified the root cause of the reported event to be a manufacturing error.The device cam pin is laser welded and should not disengage.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, at the start of the procedure during initial sealing, the jaws were noted to be attached unsteadily.Another device was opened to cope with the problem.The event occurred during the procedure, but the product was not used for patient.There was no patient involvement.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8906442
• MDR Text Key: 154740466
• Report Number: 1717344-2019-01050
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884521705910
• UDI-Public: 20884521705910
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2024
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 90940172X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1