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

Model Number	170041
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 170041, 170041 endo stitch tri 2-0 grn 18 s'dac, (lot#:j2a0645y), 170041, 170041 endo stitch tri 2-0 grn 18 s'dac, (lot#:j2a0645y), 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 laparoscopic diagnostic thoracoscopic image plicadura procedure, at the time of making a knot while repairing the diaphragm, the needle detached from the thread when the surgeon tried pulling the suture to check for breakage after finishing the cx.The issue occurred in three sutures from the same vial.The surgeon did not trust the knots and opted to start from scratch using a competitor's suture to resolve the issue.This led to 30 minutes or more extended surgical time.There was no patient injury.
Event or Problem Description
According to the reporter, during laparoscopic diagnostic thoracoscopic image plicadura procedure, at the time of making a knot while repairing the diaphragm, the needle detached from the thread when the surgeon tried pulling the suture to check for breakage after finishing the cx (surgery).The issue occurred in three sutures from the same vial.The surgeon did not trust the knots and opted to start from scratch using a competitor's suture to resolve the issue.This led to 30 minutes or more extended surgical time.There was no patient injury.
Additional Manufacturer Narrative
Correction: b5 additional information: g3 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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the image: a segment of green suture could be observed in the center of the frame.Image: a segment of green suture and an endostitch needle were observed.The needle was disengaged from the suture.Image: two segments of green suture and an endostitch needle were observed.The needle was disengaged from the sutures.It was reported that the needle was detached.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 19445176
• Report Number: 9612501-2024-01347
• Device Sequence Number: 8747586
• Product Code: OCW
• UDI-Device Identifier: 20884521127002
• UDI-Public: 20884521127002
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 09/17/2024

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: 170041
• Device Catalogue Number: 170041
• Device Lot Number: J2A0645Y
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 09/03/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/19/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2022
• 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: Male