MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2CE, GELPORT 120MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8XX2CE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: kidney transplant.Event description: the professor [name] of medical center used the device for the kidney transplant.The vinyl part of the product was torn.There was no health change.The surgery was replaced with a new device.Product is available for return.Additional information received via email 14apr2022 from applied medical operation supervisor: the tear occurred at the beginning of the processer.The nurse found that the vinyl of alexis was torn, so the ring part of the gelport did not join together with alexis.No trocars/instruments were placed directly through the gelport.The gelseal cap removed to perform anastomosis.No images are available because the torn alexis was thrown away by nurse when they found the product's flaw.Type of intervention: the surgery was replaced with a new device.Patient status: there was no problem with the patient.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The alexis of 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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: kidney transplant.Event description: the professor [name] of medical center used the device for the kidney transplant.The vinyl part of the product was torn.There was no health change.The surgery was replaced with a new device.Product is available for return.Additional information received via email 14apr2022 from applied medical operation supervisor: the tear occurred at the beginning of the procesure.The nurse found that the vinyl of alexis was torn, so the ring part of the gelport did not join together with alexis.No trocars/instruments were placed directly through the gelport.The gelseal cap removed to perform anastomosis.No images are available because the torn alexis was thrown away by nurse when they found the product's flaw.Type of intervention: the surgery was replaced with a new device.Patient status: there was no problem with the patient.

• Brand Name: C8XX2CE, GELPORT 120MM
• 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: 14221824
• Report Number: 2027111-2022-00579
• Device Sequence Number: 5308683
• Product Code: GCJ
• UDI-Device Identifier: 20607915123905
• UDI-Public: (01)20607915123905(17)231130(30)01(10)1405744
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K014047
• 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): 08/23/2022

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 Expiration Date: 11/30/2023
• Device Model Number: C8XX2CE
• Device Catalogue Number: 700314609
• Device Lot Number: 1405744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown