MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB12, 5X100 KII SH BLD ZTHR DP 10/BX; GCJ

Model Number	CTB12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: appendectomy - during appendectomy under laparoscopy, a piece of plastic was found in the abdominal cavity of the patient.This plastic has the same texture of the valve of the trocar.Additional information received from the sales rep on 23 march 2017: the customer is referring to the black seal.Patient status: unknown.
Additional Manufacturer Narrative
Two seal housings from the event units were returned to applied medical for evaluation.Upon visual inspection, the duckbill, septum and shield of both units showed no signs of damage.A septum fragment was also returned for evaluation.Engineering determined that the fragment had originated from a unit that was used in the same surgical procedure, which was reported as a separate event.Engineering was unable to confirm the customer experience of seal component separation as both units met current specifications.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: CTB12, 5X100 KII SH BLD ZTHR DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6455170
• Report Number: 2027111-2017-01665
• Device Sequence Number: 614581
• Product Code: GCJ
• UDI-Device Identifier: 00607915123529
• UDI-Public: (01)00607915123529(17)190728(30)01(10)1275569
• 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,Followup
• Report Date (Section B): 05/23/2017

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: 07/28/2019
• Device Model Number: CTB12
• Device Catalogue Number: 101413701
• Device Lot Number: 1275569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1