MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS CONTAINED EXTRACTION SYSTEM WITH GELPOINT MINI ADVANCED ACCESS PLATFORM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	GTM14
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysterectomy.Event description: the alexis ces was being used to manually morcellate a large uterus weighing approximately 890g.After morcellation the surgeon pulled up on the bag and it burst/tore along the top part proximal to the ring.The event occurred around 4 months ago and is being informed now.The surgeon does not remember the exact date.Lot number of the product is not available.Additional information was provided via email by ama territory manager associate on 12-feb-2025."since the incident occurred quite a few months ago the surgeon could not quite remember exactly which product it was.Dr [name] quoted ¿the one with the larger bag¿ which indicates gtm17 however, powerbi shows that only gtm14 was purchased.The device and packaging has since been thrown out so unfortunately, we cannot retrieve the lot number for this case." additional information was provided via email by ama territory manager associate on 19-feb-2025."the surgeon does not remember what exact model she was using however, there was a purchase of 3 units of gtm14 by [facility] back in q4 2023.I have reached out to her rooms and awaiting for a reply." intervention: na patient status: patient unaffected.
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: hysterectomy event description: the alexis ces was being used to manually morcellate a large uterus weighing approximately 890g.After morcellation the surgeon pulled up on the bag and it burst/tore along the top part proximal to the ring.The event occurred around 4 months ago and is being informed now.The surgeon does not remember the exact date.Lot number of the product is not available.Additional information was provided via email by ama territory manager associate on 12-feb-2025."since the incident occurred quite a few months ago the surgeon could not quite remember exactly which product it was.Dr [name] quoted ¿the one with the larger bag¿ which indicates gtm17 however, powerbi shows that only gtm14 was purchased.The device and packaging has since been thrown out so unfortunately, we cannot retrieve the lot number for this case." additional information was provided via email by ama territory manager associate on 19-feb-2025."the surgeon does not remember what exact model she was using however, there was a purchase of 3 units of gtm14 by [facility] back in q4 2023.I have reached out to her rooms and awaiting for a reply." intervention: na patient status: patient unaffected.

• Brand Name: ALEXIS CONTAINED EXTRACTION SYSTEM WITH GELPOINT MINI ADVANCED ACCESS PLATFORM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21601805
• Report Number: 2027111-2025-00413
• Device Sequence Number: 14546444
• Product Code: GCJ
• UDI-Device Identifier: 20607915137063
• UDI-Public: (01)20607915137063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: GTM14
• Device Catalogue Number: 700314743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown