MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB14, KII 5X55 KII SH BLD ZTHR DP 10/BX; GCJ

Model Number	CTB14
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
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 the investigation.
Event or Problem Description
Procedure performed: laparoscopic hernia repair.Event description: i was in attendance at the time of the following event.Applied medical are currently evaluating trocars in this hospital as part of aneurin bevan trust.The primary port was placed, by the surgeon mr [name].Using internal vision controlled by mr [name], his registrar ms [name] attempted to place a secondary 5 mm port (ctb14).The initial 'click' was audible on entry which suggested the blade was engaged,.She proceeded to cut through abdominal tissue and the port came in to view.The blade was clearly visable.Ms [name] suggested she had heard the secondary 'click' but the blade had not retracted as it should have done.It was obvious that though not cutting any tissue was still exposed.Ms [name] removed the bladed obturator from the cannula and continued with the procedure.No injury to the patient was caused as a result of the exposed blade.The bladed obturator was collected following the procedure, and is being kept at the theatre managers office awaiting collection.Type of intervention: surgeon removed the bladed obturator from the cannula and continued with the procedure.Patient status: did a patient injury or illness occur associated with the complaint event? no.Patient recovering normally.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant's experience could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.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: CTB14, KII 5X55 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: 6909019
• Report Number: 2027111-2017-02007
• Device Sequence Number: 750729
• Product Code: GCJ
• UDI-Device Identifier: 00607915123949
• UDI-Public: (01)00607915123949(17)200503(30)01(10)1296337
• 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,Followup
• Report Date (Section B): 02/21/2018

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: 05/03/2020
• Device Model Number: CTB14
• Device Catalogue Number: 101065801
• Device Lot Number: 1296337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/05/2017; 09/05/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/29/2017; 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1