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

Model Number	173050G
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: unknown endo ca, unknown endo catch (lot # unknown).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, in a robot-assisted partial nephrectomy, when the specimen was extracted, the shaft of the white plunger of the specimen retrieval device broke.A second device had the same issue, and additionally had its black shaft bent.The parts of the devices fell into the patient¿s cavity.After checking the device and its parts, it was assumed that all parts were extracted.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the image depicts two devices with the white shaft and ring disengaged from the black shaft.The black shaft on the bottom device was bent.The gold rings and strings were disengaged.The specimen pouches were not in view.The device was received with the bag and string fully detached to the metal ring.The bag was not received.The gold ring was disengaged from the plunger.The black sheath was disengaged from the shaft of the device.It was reported that instrument broke and component disengaged.The reported issue was not used as intended.The product analysis noted evidence that the device was not used as intended.Replication of the reported condition may occur if the plunger is retracted after bag deployment before the bag is completely cinched by pulling the green 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.A secondary review of the device histo ry records found no potentially contributing factors.The instructions included with this device provide the following guidance: warnings and precautions state: 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.
Event or Problem Description
According to the reporter, in a robot-assisted partial nephrectomy, when the specimen was extracted, the shaft of the white plunger of the specimen retrieval device broke.A second device had the same issue, and additionally had its black shaft bent.The parts ofthe devices fell into the patient¿s cavity.After checking the device and its parts, it was assumed that all parts were extracted.Another device was used to complete the case.There was no patient injury.

• 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: 23584103
• Report Number: 9612501-2025-03043
• Device Sequence Number: 9398806
• Product Code: GCI
• UDI-Device Identifier: 10884523000955
• UDI-Public: (01)10884523000955(17)270630(10)J4G4071MY
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J4G4071MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Female