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

Model Number UNKNOWN SURGIDAC SULU

Device Problems Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: 173016 - 173016 endo stitch instrument, lot# j2j2123ey.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 Description

According to the reporter, during the laparoscopic hernia repair, when using the instrument in the diaphragm, the needle completely fell off of the device in the diaphragm of the patient.The needle was not discovered after carefully and thoroughly searched.An x-ray was performed unfortunately the needle was not found.It was also noted that the device was difficult to toggle.  an additional device was then used with a new loading unit to complete the case.The patient had permanent injury as the needle was left in the patient.The surgical time was extended for more than 30 minutes as a result.

• Brand Name: UNKNOWN SURGIDAC SULU
• Type of Device: 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: 18966353
• MDR Text Key: 338432507
• Report Number: 9612501-2024-00824
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SURGIDAC SULU
• Device Catalogue Number: UNKNOWN SURGIDAC SULU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female