MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the device did not hold suture and the suture needle broke.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted the instrument was returned with no blister package with exposed blades, and blades were partially bent.The beveled walls of the instrument were inspected through a microscope and no witness marks from the needle tip impacting were found.The toggle switch of the instrument was inspected under a microscope and no shearing or deformation were observed around the toggle switch or on the flat pin.Through microscopic inspection the flat pin was found to be properly oriented and no abnormalities were observed for the center rod.The instrument's blades were bent back into the proper position.The returned instrument was loaded with a test needle from the post marketing vigilance (pmv) inventory and applied to test media.The instrument was found to function properly and test needles remained intact.Difficulty was experienced in loading, unloading and toggling the test needle in the returned instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition; therefore, a review of the device history record was not performed.A definitive root cause could not be determined with regard to the reported condition.However, probable cause could be attributed to bent/deformed metal blades which would prevent proper interaction of needle with jaw component of device.The metal blades could have been bent/deformed during return shipping to the investigations laboratory as the device was not returned in appropriate blister package, return kit or with the metal blades retracted.Metal blades could also be bent during use where the device is subjected to excessive manipulation or an leveraging force.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: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8887831
• MDR Text Key: 154122713
• Report Number: 1219930-2019-04709
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: 10884521100008
• Combination Product (y/n): N
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1