MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB01, 5X150 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB01
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event product was returned to applied medical for evaluation.Engineering functionally tested the unit and noted that the shield on the shielded bladed obturator was unable to return to the deactivated position after deployment.Engineering realigned an internal spring and the unit functioned as intended.The likely root cause of the misaligned spring is force and manipulation on the trocar during multiple attempts at insertion.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.Based on the description of the event during initial intake of the complaint, the event was not reportable as it was unlikely to cause or contribute to death or serious injury.After engineering performed their evaluation, the event is now deemed reportable due to the shield locking mechanism failure.
Event or Problem Description
Laparoscopic ovarian cystectomy - "the surgeon tried to go in with a ctf03 and couldn't gain access.He then attempted to gain access with the ctb01 after trying several times he then stated the trocar was jammed "broken".Additional information received via email from sales representative on may 18, 2016: "what i was told by the staff is the trocar jammed, meaning the button on the obturator to engage the shield would not slide over.It was stuck." patient status: "patient was fine following procedure.".

• Brand Name: CTB01, 5X150 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: 6423090
• Report Number: 2027111-2017-01621
• Device Sequence Number: 454686
• Product Code: GCJ
• UDI-Device Identifier: 00607915123994
• UDI-Public: (01)00607915123994(17)180521(30)01(10)1247399
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2017

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: 05/21/2018
• Device Model Number: CTB01
• Device Catalogue Number: 101103301
• Device Lot Number: 1247399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2016
• Initial Report FDA Received Date: 03/21/2017
• 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: SCISSORS, CTF03