MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CATCH II; LARYNGOSCOPE, ENDOSCOPE

Model Number	173049
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during an oophorectomy by videolaparoscopy using the pouch, part of the sac was loose from the ring, which hindered the process of removing the piece.The incision was extended more than 1 inch (2.54cm) due to the product problem, as the bag partially detached from the ring.To resolve the issue and complete the case, the doctor decided to open the incision to manually remove the piece.No patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that during an oophorectomy by videolaparoscopy using the pouch, part of the sac was loose from the ring, which hindered the process of removing the piece.The incision was extended more than 1 inch (2.54cm) due to the product problem, as the bag partially detached from the ring.To resolve the issue and complete the case, the doctor decided to open the incision to manually remove the piece.
Additional Manufacturer Narrative
Additional information: d9, e4, g3, h3, h6.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: ENDO CATCH II
• Common Device Name: LARYNGOSCOPE, ENDOSCOPE
• 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: 22015465
• Report Number: 9612501-2025-01280
• Device Sequence Number: 18503373
• Product Code: GCI
• UDI-Device Identifier: 10884523000948
• UDI-Public: 10884523000948
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K922123
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 173049
• Device Catalogue Number: 173049
• Device Lot Number: J4K4291HY
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 65 KG