MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Entrapment of Device (1212); Human-Device Interface Problem (2949)

Patient Problems Internal Organ Perforation (1987); Unspecified Tissue Injury (4559)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic hiatal hernia repair with nissen fundoplication, while completing the sewing of the nissen fundoplication of the stomach fundus, the device was difficult to toggle and the suture became hung up on the stomach tissue and a hole was made by the suture needle & receiving end of the instrument.The hole was deep enough into the tissue that the stomach was opened to the stomach contents/fluid.The hole/tear was closed with suture utilizing laparoscopic needle holder & knot pusher to ensure no further bleeding, tearing, or leakage of the stomach.The surgical time was extended by 30 minutes.

Manufacturer Narrative

Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the blades were partially bent and the beveled walls of the devices were inspected through a microscope and no witness marks from the needle tip impacting the beveled walls were found.No shearing or deformation were observed around the toggle switch.The flat pin and center rod were found to be without abnormality.Functionally, the blades of the device were straightened.The returned device was loaded with a test needle and applied to test media.The returned device was found to function properly and test needle remained intact.No difficulty was experienced in loading, unloading or toggling the test needle.It was reported that the tissue became stuck on the device, and the device was difficult to toggle.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the blades of the instrument were bent.The most likely cause could not be established from the information available.This issue may occur 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.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 12016153
• MDR Text Key: 256698109
• Report Number: 9612501-2021-01012
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J1A0871EY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR