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

Model Number	LS1520
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
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, intra-operatively, the tip of the device would not open properly after 3 firings.It occurred after 3-5 mins of being used.A second device was required.There was no medical intervention required.There was no patient injury.
Additional Manufacturer Narrative
One device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The investigation found the jaws opened and closed properly when the latch was retracted and released.The device was activated ten times on a saline soaked towel with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.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 MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7870329
• Report Number: 3006451981-2018-00596
• Device Sequence Number: 19317416
• Product Code: GEI
• UDI-Device Identifier: 10884524002187
• UDI-Public: 10884524002187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: 02/09/2022
• Device Model Number: LS1520
• Device Catalogue Number: LS1520
• Device Lot Number: S7BB004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1