MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number	13
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed - unknown."this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." report from the sales rep "the customer noted that the ddb was partially damaged and a portion(approx.1cm square) of the ddb was attached to be inside the seal.The customer guessed that insertion of instruments caused the incident.Septum cer check list is unavailable." initial investigation report by (b)(4): "the event unit was returned to olympus and visually inspected.The reported damage to the ddb was confirmed; the ddb was missing a portion; the missing size is approx.8.1 mm x 6.9 mm.Any portions of the ddb were not sent to olympus.No damage was observed with the septum and shield.The unit will be returned to amr for further evaluation.Admin#(b)(4)." applied medical received additional information from the distributor via email on may 8,2017: the section of the double duckbill did not fall into the patient it stayed it stayed within the seal housing.The distributor did not know what instruments were used in this port.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation along with a rubber fragment.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.The rubber fragment returned matched the missing portion on the seal.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: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6596121
• Report Number: 2027111-2017-01820
• Device Sequence Number: 867239
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)191103(30)01(10)1282992
• Combination Product (Y/N): N
• PMA/510(K) Number: 13
• 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): 06/08/2017

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: 11/03/2019
• Device Model Number: 13
• Device Catalogue Number: 13
• Device Lot Number: 1282992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1