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

Model Number	173050G
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, the bag burst when removing the pouch through the port incision.The bag material was too thin/flimsy.A new endo catch was used to resolve the issue.There was no patient 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.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the device was received with the bag and string fully detached from the metal ring.There was a hole in the bag.There was shrink wrap still attached to the metal ring.The gold ring was not received.Functional testing noted that the plunger and metal ring advanced and retracted properly.It was reported that the bag was torn.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the plunger is retracted after bag deployment before the bag is completely cinched by pulling the gold ring.This premature retraction causes undesirable bag detachment.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: if bag does not pull through easily, enlarge the incision to accommodate easy removal for specimens with diameters larger than the trocar site incision.Failure to follow this warning could cause the bag to break and the specimen to fall back into the body cavity.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 GOLD
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22983081
• Report Number: 9612501-2025-02352
• Device Sequence Number: 9549332
• Product Code: GCI
• UDI-Device Identifier: 10884523000955
• UDI-Public: (01)10884523000955(17)280331(10)J5D3570MY
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J5D3570MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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