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

Model Number	170002
Medical Device Problem Codes	Difficult to Open or Close (2921); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 173016, 173016 endo stitch instrument (lot#: j5a2359ey).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 one anastomosis gastric bypass procedure, a small hiatal hernia was identified and the device was used to close the space between the pillars and the surgeon had to use both hands to close the device.The device was difficult to toggle and unload and after removal from the patient cavity, the jaws could not be opened and the nurse could not retrieve the reload.Another device was opened and reloaded to complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d9, 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 returned loaded in an instrument and was removed for further inspection.The needle was received improperly loaded/backwards.A suture was returned unattached to the needle.Microscopic inspection of the needle noted loading blade damage to the back of the needle opposite to the loading slot.The needle had to be broken in order to remove it from the instrument.It was reported that the jaws were difficult to open, difficult to toggle, and difficult to unload.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur if either the device had incorrect orientation or the suturing device was held with the printed information facing down when the needle was loaded in the device.In some instances, the needle became lodged between the jaw and the slot of the blade, making it impossible to unload.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 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: SOFSILK
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22470244
• Report Number: 9612501-2025-01786
• Device Sequence Number: 15417214
• Product Code: OCW
• UDI-Device Identifier: 20884521126852
• UDI-Public: (01)20884521126852(17)290228(10)J4C2494Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 170002
• Device Catalogue Number: 170002
• Device Lot Number: J4C2494Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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.
• Patient Sex: Female