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

Model Number	LF1537
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was a mechanical issue with the device during a procedure.The device¿s cutting button did not bounce back after activating.Another device was used but the same issue occurred again.There was no injury caused to the patient and no medical intervention was required.No additional information was provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: two devices were received for evaluation.These devices have been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the products were within the assigned expiration date at the time of the reported incident.The returned products met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The jaws opened and closed properly when the handle was retracted and released.The knife blade advanced and retracted smoothly along the knife track.The knife cut of the devices were tested on a silicone test strip with acceptable results.The devices were 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 device was activated with the rotation knob in various positions to detect any problematic activation issues.The investigation found the devices to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, two devices were used and their jaws were difficult and impossible to open.There was no injury caused to the patient and no medical intervention was required.

• 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: 7065034
• Report Number: 1717344-2017-06289
• Device Sequence Number: 126377
• Product Code: GEI
• UDI-Device Identifier: 20884524002290
• UDI-Public: 20884524002290
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 04/01/2020
• Device Model Number: LF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 50850204X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 06/26/2018; 08/08/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 07/23/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1