MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R83, 12X60 KII OPT ZTHR 6/BX; GCJ

Model Number	C0R83
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of leakage due to a torn and fragmented internal rubber component of the seal.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of event to occur.This report represents the initial and final report.
Event or Problem Description
Procedure performed: "liver cancer".Event description: "during the surgery, when co2 insuflation started, air leak was found." type of intervention: unknown.Patient status: "no patient injury".

• Brand Name: C0R83, 12X60 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6922375
• Report Number: 2027111-2017-02050
• Device Sequence Number: 13804788
• Product Code: GCJ
• UDI-Device Identifier: 00607915116668
• UDI-Public: (01)00607915116668(17)191018(30)01(10)1281690
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: 10/18/2019
• Device Model Number: C0R83
• Device Catalogue Number: 101218501
• Device Lot Number: 1281690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1