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

Model Number LF5637

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Injury (2348); Bowel Perforation (2668); No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the surgeon was using both a device and ultrasonic for dissection.The patient had multiple adhesions which the surgeon used the device to dissect prior to mobilizing the ligaments and vessels of one ovary and the uterus.Initially, the surgeon utilized the harmonic device to dissect and mobilize these tissues.The case started at 8:11am, and at 9:19am, the device was opened onto the sterile field for use.As the surgeon approached the "ip" or infundibulopelvic ligament, the surgeon switched from the ultrasonic to the device to seal/divide these vessels.The surgeon continued use of the device to dissect and seal the round ligaments.At approximately 9:55am, the device became bent and mis-shapen at the flexible catheter tip of the instrument.After the instrument was bent, it was no longer usable.The surgeon then continued dissection of the broad and cardinal ligaments with the device.The surgeon utilized a standard laparoscopicl-hook electrode for the colpotomy creation.The uterus was removed vaginally and the vaginal cuff repaired.The device was utilized for approximately 36 minutes during the entire procedure, which started at 8:11am and finished at approximately 11:40am, a duration of 3 hours and 29 minutes.On post-op day 10, patient was admitted to hospital where it was determined from a ct scan, she experienced a bowel tear and/or perforation, as well as damage to her right lateral ureter.Patient then required two additional surgeries.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.Visual inspection found the device was bent at the sheath/composite shaft junction.All pieces were still attached.The reported condition was confirmed.The investigation found the device was bent at the sheath/composite shaft junction.Engineering found the shaft was bent near the jaws.The customer reported that the device bent during use.The reported condition was confirmed.The investigation found the shaft was bent and partially broken near the jaws, refer to the ct scan below.This is indicative of the shaft being flexed too far.The investigation identified the root cause of the reported event to be user error.The instructions for use(ifu) states, do not bend the instrument shaft.The investigation identified the root cause of the reported event to be user error.The ifu states, do not bend the instrument shaft.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: LIGASURE HOOK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8584903
• MDR Text Key: 144241900
• Report Number: 1717344-2019-00595
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: 10884521521735
• Combination Product (y/n): N
• PMA/PMN Number: K161804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2020
• Device Model Number: LF5637
• Device Catalogue Number: LF5637
• Device Lot Number: 82360041X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention