MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF1212A
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.No product defects were visible in the picture.The pictures showed a used device.The reported incident could not be confirmed from the provided photo.The provided photos are not sufficient to investigate the failure mode.The file will be closed as unconfirmed at this time.If additional information is obtained, or the product is returned, we will re-open this investigation.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the clamp performed the seal intermittently with end tone, cleaned very well and several times the clamp.Restarted the generator, changed the clamp from one port to another, but issue was not solved.Finally, the clamp was changed with a new one thus solving the problem.There was no patient injury.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 8422028
• Report Number: 3006451981-2019-00042
• Device Sequence Number: 303452
• Product Code: GEI
• UDI-Device Identifier: 10884521186033
• UDI-Public: 10884521186033
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K152286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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: 05/09/2023
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: S8EH715X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR