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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 173049, 173049 endo catch ii 15mm pouch, (lot # j5j2799hy) 173049, 173049 endo catch ii 15mm pouch, (lot # j3l2870hy).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 minimally invasive laparoscopic procedure for the removal of a large cyst with significant fluid content, three bags were each found to be broken when entered through a 15mm port, and the bag was partially detached from the ring.The device was being applied when moving the cyst out from the abdomen.Despite the breakage of all three bags, the surgical team succeeded in using the last broken bag to remove the cyst from the body and no specimen fell into the patient.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and photos were available for evaluation.Visual inspection noted that the pull string was attached at the base of the pouch.The green ring was attached to the handle.Device was returned with metal ring fully deployed.The specimen pouch was disengaged and not received.Functional testing found that the plunger was pulled and the metal ring retracted completely into the shaft of the instrument without difficulty.The plunger was pushed and flexible metal ring protruded without difficulty.It was reported that the bag partially separated from the ring.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if removal of specimen pouch is attempted through an inadequately sized removal site; there will be pressure exerted on the specimen pouch, usually in the distal end, where there will be stretching and deforming of the specimen pouch until it subsequently rips under tension.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: ensure that the metal ring is retracted completely into the instrument prior to removal through the trocar sleeve.Do not attempt to pull pouch through the trocar sleeve or shaft of instrument.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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23732914
• Report Number: 9612501-2025-03257
• Device Sequence Number: 21484668
• Product Code: GCI
• UDI-Device Identifier: 10884523000948
• UDI-Public: (01)10884523000948(17)300630(10)J5G4132HY
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 03/09/2026

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: 173049
• Device Catalogue Number: 173049
• Device Lot Number: J5G4132HY
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown