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

Model Number	LF1212A
Medical Device Problem Codes	Energy Output To Patient Tissue Incorrect (1209); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure the device was producing partial seals with no re-grasp alerts.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Upon receipt of the new information this report has been downgraded from a malfunction to a complaint as there is minimal risk of that the device could cause or contribute to a death or serious injury if to recur.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the instrument had a partial seal but there were re-grasp alerts.There was no endtone and there was an incomplete seal message on the monitor.Another lf1212a was used with the generator and it worked properly.No patient injury.New information received stated that an audible sound alert that sealing cycle was not complete was heard and it was identified that sealing was not concluded and appeared orange sign in the monitor.Because the sealing cycle was not completed the device was changed for other lf1212a.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found no defects.The reported condition was confirmed.The investigation found there was open resistance between the p jaw and the power pin.The device showed immediate regrasp alarm upon activation.The device was split open to find out the solder sleeve has a defect.A defect was found at the sleeve connection area.The cable of the p jaw was not fully inserted into the sleeve.Visual inspection on the sleeve connection.A defect was found at the sleeve connection area.The cable of the p jaw was not fully inserted into the sleeve.After reviewing the dhr, engineering found that the device passed all production tests.Engineering determined that the failure was created during later use, (e.G., when the cable was pulled).The welding area is weak due to the welding defect, and the connection opened when the cable was pulled.This caused the open circuit and sealing failure.During manufacturing, some operators may put the blue wires with the red and brown cable wires into the sleeve at the same time.Since the blue wire was very fine, there is a potential risk of the blue wire being blocked by the tin ring and not fully inserted into the sleeve.Therefore, it is defined as plant/ manufacturing cause.The investigation identified the root cause of the reported event to be manufacturing.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: 7072055
• Report Number: 3006451981-2017-05815
• Device Sequence Number: 1159276
• Product Code: GEI
• UDI-Device Identifier: 20884521186030
• UDI-Public: 20884521186030
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K102470
• 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,Followup
• Report Date (Section B): 12/12/2018

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: 11/08/2021
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: S6LH008X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017; 10/18/2018; 11/20/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/08/2018; 11/12/2018; 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62