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

Model Number	173024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: 173016, 173016 endo stitch instrument (lot #j4h2659ey) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a laparoscopic hiatal hernia repair using the instrument, the needle broke during suturing, and half of the needle was left in the patient.The surgical team opened another device to complete the procedure.
Additional 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 that no suture was returned with the needle.Functional testing found that since the needle was returned broken functional testing could not be performed on the returned sample.It was reported that the needle was broken.The reported issue was confirmed.The most likely cause could not be established from the information available.Internal process improvements have been initiated to mitigate this issue.The evaluation detected an unreported condition of premature toggle that had no relationship to the reported condition.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: prior to loading, ensure that the metal bars are fully extended.If the metal bars are not extended, follow the unloading instructions prior to loading the device.Insert the tip of the open jaws, with the logo facing up, into the reload and press firmly until fully seated.Squeeze the handles together and pull both toggle levers back until you hear an audible click.Now the toggle levers are fully activated.Take note that the black loading buttons will cover the red indicator boxes.Press down on the reload tab and remove the device and entire length of suture.To guide the needle through the tissue, close the jaws by completely squeezing the handles and reversing the position of the toggle levers until they stop.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21759801
• Report Number: 9612501-2025-00933
• Device Sequence Number: 18295468
• Product Code: OCW
• UDI-Device Identifier: 10884521129450
• UDI-Public: 10884521129450
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 173024
• Device Catalogue Number: 173024
• Device Lot Number: J4H2536Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown