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	11/26/2017
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.
Event or Problem Description
According to the reporter, the first device could not be closed and the second device was difficult to activate.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the device welding was damaged.The reported condition was confirmed.The investigation found the device welding was cracked and damaged.Further investigation found the device was difficult to close and has to be forced close.The damage to the handle welding affected the device closing mechanism.The investigation identified the root cause of the reported event to be user mishandling the device.A damaged device welding is consistent with misuse or subjecting a device to multiple uses or reprocessing.The instructions for use (ifu) states, use caution when grasping, manipulating, sealing, and dividing large tissue bundles.The ifu also states, this product is designed as a single use device.It has only bee n evaluated in testing to simulate single-use conditions.Subjecting the product to reprocessing or multiple uses could potentially affect the structure and components which could affect the function of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the first device could not be closed and the second device was difficult to activate.It had no energy output.A new device can be used as normal after device replacement.No patient injury.
Additional Manufacturer Narrative
Further evaluation of the issue confirmed that there is no patient injury or risk of patient injury associated with this complaint.This is no longer classified as a reportable issue, and no further reports will be sent unless information is received that changes the reportability of the file.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: 7085082
• Report Number: 1717344-2017-06340
• Device Sequence Number: 1495446
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2018

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: 06/13/2018
• Initial Date Received by Manufacturer: 11/26/2017
• Supplement Date Received by Manufacturer: 11/26/2017; 06/14/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/06/2017; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1