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

Model Number	LF1744
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the bottom jaw overmold was damaged and missing plastic.The disengaged plastic was returned.The reported condition was confirmed.The damage to the jaw's overmold likely occurred during the insertion or extraction of the device jaw from a trocar instrument.The investigation identified the root cause of the reported event to be user error.The instruction for use (ifu) states, carefully insert and withdraw the instrument through the cannula to avoid damage to the device and or injury to the patient.Close jaws using device handle before insertion/extraction in the trocar.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while the device was used with generator, the tip of the device was broken.The sales rep will visit the customer's facility to confirm the lot number and the device.He/she will report the lot and device's condition when the information is confirmed.The procedure was completed with another device.Nothing fell into the patient's cavity.No patient harm.Initial investigation found the bottom jaw overmold was damaged and missing plastic.The disengaged plastic was returned.

• 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: 8101416
• Report Number: 1717344-2018-01529
• Device Sequence Number: 1098326
• Product Code: GEI
• UDI-Device Identifier: 10884521181564
• UDI-Public: 10884521181564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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 Model Number: LF1744
• Device Catalogue Number: LF1744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1