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	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: kt donor.Event description: [name] medical center.The device was being used for kt donor.No external physical force was applied to the device during the surgery, but the film attached to alexis' white ring was torn.The gas leaked, so it was replaced with a new device.There was no health change.The case was completed with a new device.Product is available for return.Additional information was received via email on 04oct2022 from [name], ra/qa specialist [facility]: "product was torn while it was being used to patient.The product was removed and replaced with new one.Surgeon's hand was inserted into the device.The tear did not occur during removal." the sheath tore near the white outer ring.There were no trocars/instruments placed directly through the gelport.There was no anastomosis.Patient status: there was no patient injury.Type of intervention: the case was completed with a new device.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed a tear in the sheath.It was noted that the tear had rough edges.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.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: kt donor event description: [name] medical center.The device was being used for kt donor.No external physical force was applied to the device during the surgery, but the film attached to alexis' white ring was torn.The gas leaked, so it was replaced with a new device.There was no health change.The case was completed with a new device.Product is available for return.Additional information was received via email on 04oct2022 from [name], ra/qa specialist [facility]."product was torn while it was being used to patient.The product was removed and replaced with new one.Surgeon's hand was inserted into the device.The tear did not occur during removal." the sheath tore near the white outer ring.There were no trocars/instruments placed directly through the gelport.There was no anastomosis.Patient status: there was no patient injury.Type of intervention: the case was completed with a new device.

• 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: 15547585
• Report Number: 2027111-2022-00766
• Device Sequence Number: 11239061
• Product Code: GCJ
• UDI-Device Identifier: 20607915123905
• UDI-Public: (01)20607915123905(17)240908(30)01(10)1432040
• 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): 12/09/2022

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: 09/08/2024
• Device Model Number: C8XX2CE
• Device Catalogue Number: 700314609
• Device Lot Number: 1432040
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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
• Patient Sex: Unknown