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

Model Number	5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: "unknown (used for procedure related to esophagus)" incident description: "this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." report from the sales rep "during a procedure, the customer noted two petals of the shield fell off inside abdominal cavity.The procedure was successfully completed with them removed from the patient using a grasper.He mentioned the shield was likely cut using a scissors.He complained that parts potentially falling inside abdominal cavity should not be transparent color, in the light of identification.The septum and the ddb were cut for a check inside the seal." initial investigation report by (b)(4): "the event unit was returned to olympus and visually inspected.It was noted that the septum and the ddb were cut for a check inside the seal by the facility.Confirmed that the shield was fragmented and missing a portion.The returned petals are similar to the missing site of the shield in shape.The unit will be returned to amr for further evaluation.Admin#(b)(4)." type of intervention: "the procedure was successfully completed with them removed from the patient using a grasper".Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering noted the shield, an internal component of the seal, was torn and fragmented.Two fragmented petals from the shield were returned for evaluation.The likely root cause of the damage to the seal is 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 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: 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: 6494209
• Report Number: 2027111-2017-01698
• Device Sequence Number: 1122578
• Product Code: GCJ
• UDI-Device Identifier: 00607915116668
• UDI-Public: (01)00607915116668(17)190811(30)01(10)1277186
• Combination Product (Y/N): N
• PMA/510(K) Number: 5
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: Other
• Device Expiration Date: 08/11/2019
• Device Model Number: 5
• Device Catalogue Number: 5
• Device Lot Number: 1277186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/19/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DISSECTOR, SCISSORS, 10MM RIGID TELESCOPE; LIGASURE MARYLAND, HOOK, HARMONIC ACE +7