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

Model Number	CNGL3
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Name of procedure being performed: unknown at this time.The bag and the ring come off in the abdominal cavity.Further details will follow.Pick up address will follow.Patient status: unknown at this time.Type of intervention: unknown.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was/were provided by the complainant.Visual inspection confirmed the complainant¿s experience of sheath separation.Based on the photo provided by the complainant, it is likely that the reported event was caused by unflipping of the inner ring.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented material enhancements intended to further minimize the potential for this type of event to occur.The event unit was manufactured prior to the implementation of the material enhancements.
Event or Problem Description
Name of procedure being performed: laparascopiy gyn surgery the bag and the ring come off in the abdominal cavity.Further details will follow.Pick up address will follow.Additional info received 22oct2018 from sales rep.We received the below email from the customer from (b)(4) that the event sample is not coming back since they threw it out.Additional info received 23oct2018 from sales rep.During the lap gyn procedure the bag and the ring come off in the abdominal cavity.There were no other abnormalities.Patient status: fine.Type of intervention: unknown.

• 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: 8035682
• Report Number: 2027111-2018-00409
• Device Sequence Number: 1465234
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)210329(30)01(10)1321366
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 12/20/2018

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: Health Professional
• Device Expiration Date: 03/29/2021
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1321366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1