MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering noted fragmentation of an internal rubber component of 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.This report represents the initial and final report.
Event or Problem Description
Procedure performed: bypass.Event description: during bypass after introduction of a 5mm grasper, the surgeon observed a leakage by the seal.As a consequence the patient started to loose pneumoperitoneum.The surgeon took a second device and observed the same leakage problem.The surgeon took a third device and observed the same leakage problem.He took the seal of a fourth device and placed the seal on the third device.He also observed a leakage by the seal.The surgeon reported that this event delayed the procedure by 1 and half hour.The surgeon would like a credit on all units.Type of intervention: unknown.Patient status: no patient injury or illness occurred associated with the complaint event.

• Brand Name: CTB73, 12X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6843038
• Report Number: 2027111-2017-01976
• Device Sequence Number: 706112
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)191228(30)01(10)1286351
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• 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
• Report Date (Section B): 09/05/2017

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: 12/28/2019
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1286351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1