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

Model Number	173049
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
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
According to the reporter, during a laparoscopic colorectal low anterior resection (lar), on the final part of the specimen removal, the bag tore while trying to bag the specimen.A new device from a different manufacturer was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A visual inspection of the returned product noted that the pull string was cinched at the base of the pouch.The pull was attached to the handle.The device was returned with metal ring fully deployed.The specimen pouch had completely separated from the ring.Functionally, 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 tore while trying to bag the specimen.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.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20152736
• Report Number: 9612501-2024-02244
• Device Sequence Number: 8368929
• Product Code: GCI
• UDI-Device Identifier: 10884523000948
• UDI-Public: 10884523000948
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/17/2024

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: J4B2978HY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Patient Sex: Prefer Not To Disclose