MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF34, KII FIOS 11X100MM Z-THR W/HD 6/BX; GCJ

Model Number	CTF34
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2016
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 investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Laparoscopic cystectomy - "the handle of obturator fits loose into the sleeve.Was not used for procedure." additional information received from distributor via email on november 23, 2016: "the obturator fit loosely into cannula it was packaged with.Was not used with additional sleeves." patient status - unk.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering was able to confirm the complainant's experience of a loose obturator handle.The unit was returned with the handle detached from the obturator.There was damage observed on the female mating features of the obturator shaft.It is likely that the detachment of the handle from the obturator resulted from a build-up of internal stresses associated with the press-fit of the shaft into the handle.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: CTF34, KII FIOS 11X100MM Z-THR W/HD 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6179679
• Report Number: 2027111-2016-00851
• Device Sequence Number: 11019324
• Product Code: GCJ
• UDI-Device Identifier: 00607915124229
• UDI-Public: (01)00607915124229(17)120220(30)01(10)1214167
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: 02/20/2017
• Device Model Number: CTF34
• Device Catalogue Number: 101061601
• Device Lot Number: 1214167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1