MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2, GELPORT 120MM; GCJ

Model Number	C8XX2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Name of procedure being performed: lap hand assisted donor nephrectomy.Detailed description of event: ¿during procedure the hand entry tore.They would like an investigation to be completed.They do have the sample for return.Limited information available." additional information received via email from account manager associate, on tuesday, 16apr2019: procedure was lap hand assisted donor nephrectomy.The device was removed, another one opened.The procedure was completed.The surgeon's hand was not inserted into the device at the time of the gel separation.The gelseal cap and the surgeon's hand was lubricated prior to hand access.The gel started to detach immediately when the device was in use.Additional information received via telephone from account manager associate, on tuesday, 30apr2019: the correct product was returned.The issue is not with the gel but with the alexis sheath torn.Intervention: device removed, another one opened.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear in sheath material.Based on the condition of the returned unit, it is likely the reported event was caused by the instrumentation used during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.
Event or Problem Description
Name of procedure being performed lap hand assisted donor nephrectomy.Detailed description of event: ¿during procedure the hand entry tore.They would like an investigation to be completed.They do have the sample for return.Limited information available".Additional information received via email from account manager associate, on tuesday, 16apr2019: procedure was lap hand assisted donor nephrectomy.The device was removed, another one opened.The procedure was completed.The surgeon's hand was not inserted into the device at the time of the gel separation.The gelseal cap and the surgeon's hand was lubricated prior to hand access.The gel started to detach immediately when the device was in use.Additional information received via telephone from account manager associate, on tuesday, 30apr2019: the correct product was returned.The issue is not with the gel but with the alexis sheath torn.Type of intervention: device removed, another one opened.Patient status: no patient injury.

• Brand Name: C8XX2, GELPORT 120MM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8591262
• Report Number: 2027111-2019-00441
• Device Sequence Number: 16662782
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)210131(30)01(10)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: C8XX2
• Device Catalogue Number: 700025401
• Device Lot Number: 1339194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1