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

Model Number	170013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: unknown estitch, unknown endo stitch instrument (lot#unknown); 170013, 170013 endo stitch 2-0 blk 120cm bralon (lot#j4a3029y).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 the nurse had ensured the suture was properly loaded on to the instrument and when the surgeon inserted the device into the trocar, the surgeon immediately noticed that the needle was broken in two.On the second suture, the needle was not properly placed in the packaging when opened prior to use during a laparoscopic procedure.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.Correction: d10.D10 concomitant products: 173016, 173016 endo stitch instrument (lot# unknown) 170013, 170013 endo stitch 2-0 blk 120 cm bralon (lot# j4a3029y).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 paraesophageal herniorrhaphy, the nurse had ensured the suture was properly loaded on to the instrument and when the surgeon inserted the device into the trocar, the surgeon immediately noticed that the needle was brokenin two.On the second suture, the needle was not properly placed in the packaging when opened prior to use during the procedure.It was noted that there was no needle left inside the patient.There was no patient injury.
Additional Manufacturer Narrative
Correction: e1 (first name, last name).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: BRALON
• 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: 22231394
• Report Number: 9612501-2025-01539
• Device Sequence Number: 12767371
• Product Code: OCW
• UDI-Device Identifier: 20884521126982
• UDI-Public: 20884521126982
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/07/2025

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: 170013
• Device Catalogue Number: 170013
• Device Lot Number: J4A3029Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 06/16/2025; Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/30/2025; 06/30/2025; 07/07/2025
• Date Device Manufactured: 01/11/2024
• 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
• Patient Sex: Unknown