MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL3, GELPOINT MINI ADV ACCESS PLATFORM; GCJ

Model Number	CNGL3
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation, but a lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: laparoscopic cystectomy.Event description: "surgeon placed the (b)(6) and during the sweep for bowel entrapment the plastic sheath tore.The surgeon did not have any sharp objects nearby during this process." type of intervention: "the product was removed and disposed of." patient status: ni.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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.

• Brand Name: CNGL3, GELPOINT MINI ADV ACCESS PLATFORM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7580923
• Report Number: 2027111-2018-00188
• Device Sequence Number: 16641295
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)210111(30)01(10)1314929
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 01/11/2021
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1314929
• 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: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/05/2018
• Patient Sequence Number: 1