MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GTK14, ALEXIS CES 14CM W KII BALLOON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	GTK14
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: hysterectomy event description: according to the surgeon, potentially during the manual morcellation stage of the procedure.Applied medical rep not present during case.During a robotic case, the bag was deployed inside the patient, the bag opened up, surgeon commented that vision of robotic instruments may have been obscured at the stage by the bag the uterus and tubes were placed inside the bag, a photo was captured at this time and all appeared normal.Manual morcellation took place and the surgeon noticed fatty tissue and bright red blood.Surgeon then took the hassan port robot arms off, took out specimen, re-established pneumo, went back to the console and called for the assistance of a general surgeon to repair the mesenteric vessel which had been cut.Surgeon noticed the bag had been cut.Mesenteric vessel had been cut requiring repair and subsequent 2 units of blood given post surgery.Patient also complaining of upset stomach and is being monitored by general surgeon who was called in to assist.Device removed and surgical intervention to repair tissue damage.Other instruments used when the complaint event occurred: [name] robot, robotic ports and standard instrumentation intervention: device removed and surgical intervention to repair tissue damage.Patient status: according to surgeon, patient recovering ok with no long-term complications likely.Patient needed to receive 2 units of blood post-surgery.
Event or Problem Description
Procedure performed: hysterectomy event description: according to the surgeon, potentially during the manual morcellation stage of the procedure.Applied medical rep not present during case.During a robotic case, the bag was deployed inside the patient, the bag opened up, surgeon commented that vision of robotic instruments may have been obscured at the stage by the bag the uterus and tubes were placed inside the bag, a photo was captured at this time and all appeared normal.Manual morcellation took place and the surgeon noticed fatty tissue and bright red blood.Surgeon then took the hassan port robot arms off, took out specimen, re-established pneumo, went back to the console and called for the assistance of a general surgeon to repair the mesenteric vessel which had been cut.Surgeon noticed the bag had been cut.Mesenteric vessel had been cut requiring repair and subsequent 2 units of blood given post surgery.Patient also complaining of upset stomach and is being monitored by general surgeon who was called in to assist.Device removed and surgical intervention to repair tissue damage.Other instruments used when the complaint event occurred: [name] robot, robotic ports and standard instrumentation intervention: device removed and surgical intervention to repair tissue damage.Patient status: according to surgeon, patient recovering ok with no long-term complications likely.Patient needed to receive 2 units of blood post-surgery.
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.The complainant did not allege any malfunction with an applied medical device.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 bag tear.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: GTK14, ALEXIS CES 14CM W KII BALLOON
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16857250
• Report Number: 2027111-2023-00431
• Device Sequence Number: 8576607
• Product Code: GCJ
• UDI-Device Identifier: 20607915137070
• UDI-Public: (01)20607915137070(17)240914(30)01(10)1435452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142427
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: GTK14
• Device Catalogue Number: 700314236
• Device Lot Number: 1435452
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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: STANDARD INSTRUMENTATION; [NAME] ROBOT, ROBOTIC PORTS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown