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

Model Number	LF1520
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during a procedure, the jaws of the device did not open after sealing.The jaws were opened manually, resulting in under 200cc of blood loss.A new device was used to continue the procedure and there was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one used lf1520 ligasure device was received, and an evaluation confirmed the reported issue.Visual inspection found the device was returned with tissue stuck between closed jaws.The jaws could not be opened using the handle.Disassembly found the issue was from a loose metal clip within the device body.There were no other signs of body or component damage, indicating that it was manufactured and functioned properly when it left the factory.A review of the device history records found no potentially contributing factors from the manufacturing process.The investigation identified the root cause of the reported event to be a clip that became loose during use.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: 6799411
• Report Number: 1717344-2017-05729
• Device Sequence Number: 138624
• Product Code: GEI
• UDI-Device Identifier: 10884521125520
• UDI-Public: 10884521125520
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092879
• 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,Followup
• Report Date (Section B): 10/23/2017

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: 02/28/2021
• Device Model Number: LF1520
• Device Catalogue Number: LF1520
• Device Lot Number: 60400085X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1