MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS CONTAINED EXTRACTION SYSTEM; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	GTB17
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnotes histerectomy.Event description: they were trying to open the bag inside the abdomen.The surgeon was trying to open the bag pulling the strap with snap fastener in order open the bag inside the abdomen with the grasper the strap broke.Besides one the manipulation tabs also broke when the surgeon tried to remove the white ring.They managed to open and removed the bag and complete the manual morcelation.With no problems.Intervention: they managed to open and removed the bag and complete the manual morcelation with no problems.Patient status: the patient is ok.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided upon the completion of the investigation.
Event or Problem Description
Procedure performed: vnotes histerectomy.Event description: they were trying to open the bag inside the abdomen.The surgeon was trying to open the bag pulling the strap with snap fastener in order open the bag inside the abdomen with the grasper the strap broke.Besides one the manipulation tabs also broke when the surgeon tried to remove the white ring.They managed to open and removed the bag and complete the manual morcelation.With no problems.Additional information received from applied medical representative via email on 12may25: the specimen was manually morcellated for removal.Scalpel was used to morcellate the specimen.The guard was used.Alexis was used.The ring was rolled down to bring the specimen to the surface.No bag removal attempted before removing all the tissue.No unintentional tissue damage.Intervention: they managed to open and removed the bag and complete the manual morcelation with no problems.Patient status: the patient is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of tab separated from ring.Based on the condition of the returned unit and the description of the event, it is likely that the separated occurred due to the user pulling on the tab with excessive force while manipulating or removing the containment bag.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: ALEXIS CONTAINED EXTRACTION SYSTEM
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• 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: 21971962
• Report Number: 2027111-2025-00512
• Device Sequence Number: 8692042
• Product Code: KGW
• UDI-Device Identifier: 00607915134280
• UDI-Public: (01)00607915134280
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: 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: GTB17
• Device Catalogue Number: 101475755
• Device Lot Number: 1538612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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: ENDOCLINCH; REUSABLE GRASPER
• Patient Sex: Unknown