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

Model Number	173024
Medical Device Problem Codes	Break (1069); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: 173024 - 173024 endo stitch 0 grn 120 surgidac, lot# j4d3113y 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
According to the reporter, during a laparoscopic hiatal hernia repair, during pexying the stomach to the esophagus, the scrub nurse noted that the stitch was hard to load onto the handle.It felt jammed and the device was difficult to toggle.The nurse observed that the device appeared to be loaded though and handed it off to the surgeon to use.Upon the first bite of stomach tissue for the fundoplication, the needle snapped in half right where the suture was gathered.The surgeon had to retrieve the needle from the patient's stomach and do a series of steps to ensure the safety for the patient.As a precaution that all of the foreign objects were retrieved, the surgeon performed an x-ray after the surgical portion was completed.Surgical time was extended for more than 30 minutes and the surgeon ended up free-stitching the rest of the case.
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 the needle was broken at the suture attachment point, and both sides of the needle were returned.A suture was returned unattached to the needle.The suture was measured with a metal ruler, calibrated asset, and found the suture length to be 6.5 inches.The original suture length was 48 inches.It was reported that the device was difficult to load, to toggle, and the needle was broken.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue of a broken or bent needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break.The evaluation detected an unreported condition: damage to the needle cones.Visual examination noted that, on microscopic inspection of the needle fragments, damage to the cones was observed, and damage to the tip of one of the needles was observed.The product analysis noted evidence that the device was not used as intended.This issue may occur when pressure is applied to the toggle lever of the suturing device prior to closing the handles and prematurely attempting to toggle.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: ensure that the toggle levers are fully retracted prior to opening the jaws of the device.The reloading button should never be pressed when the instrument is in the body cavity, as this will release the needle.Inspect the application site to ensure hemostasis.Place additional sutures or use electrocautery if necessary to complete hemostasis.Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient.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: 19928419
• Report Number: 9612501-2024-01928
• Device Sequence Number: 2797780
• Product Code: OCW
• UDI-Device Identifier: 10884521129450
• UDI-Public: 10884521129450
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/10/2024

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: J4D3113Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: Male