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

Model Number	LF1537
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that during a procedure, a metal piece below the jaw detached.No patient injury resulted or medical intervention was required.
Additional Manufacturer Narrative
Evaluation summary: a sample was received, and an examination of the device confirmed a device issue.The device had been used in the treatment or diagnosis of a patient.The returned product did not meet specification as received.Visual inspection found the metal flange on the device jaw was damaged.The metal flange that pulls the inner tube to open the jaw was broken but still attached to the device jaw.The tube is made of stainless steel and should not break without exerting excessive force or abuse.Further investigation found that the device knife blade was also able to deploy while the jaw was opened.The damage to the metal flange of the device is consistent with a device that has been subjected to reprocessing or multiple uses.The damage flange also affected the device jaw mechanism allowing the knife blade to deploy while the jaws are open.The investigation identified the root cause of the damaged flange to be user error.The ifu warns: this product is designed as a single use device.It has only been evaluated in testing to simulate single use conditions.Subjecting the product to reprocessing or multiple uses could potentially impact the structure and components of the device.Additional info: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: 6927498
• Report Number: 1717344-2017-06015
• Device Sequence Number: 11072506
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 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: 10/27/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 10/07/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1