MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB33
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap appendix.At the end of the procedure, whilst removing the specimen through the trocar, the or staff noticed that pinch tab broke and seal housing dislodged.The tab fell but outside the patient.They did not use another trocar because the procedure was finished already.Patient status: not affected.Patient is fine.
Additional Manufacturer Narrative
The cannula of the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a broken cannula tab.Engineering was able to replicate the broken tab by repeatedly applying downward and upward forces on the remaining tab until breakage.Based on the condition of the returned unit and testing performed during the evaluation, the exact root cause could not be confirmed.The probability and criticality of this failure have been evaluated and were found to be at an acceptable level.Although the exact root cause of the reported event could not be determined, 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: CTB33, 11X100 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: 7491264
• Report Number: 2027111-2018-00162
• Device Sequence Number: 11117189
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)201017(30)01(10)1308777
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 05/21/2018

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: 10/17/2020
• Device Model Number: CTB33
• Device Catalogue Number: 101472323
• Device Lot Number: 1308777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM SLEEVE, 5MM TROCAR, 5MM JOHAN GRASPER; 5MM MONOPOLAR HOOK, RETRIEVAL SYSTEM (NOT APPLIED)