MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q61,KII 8X100MM ZTHR SHLD BLD SYS 6/BX; GCJ

Model Number	C0Q61
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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
Procedure performed: unknown - "when the scrub attempted to insert obturator into cannula, it would not fit.That is when they discovered the plastic piece for the blade shield had popped out.Dr.(b)(6) was the surgeon." additional information received via email from (b)(6) on september 22, 2016 - "the trocar had no contact with the patient, because they were never able to put the trocar together".See attaching pictures for explanation of malfunction."i was told by the materials manager that the scrub tech was getting the products ready for the case and when she went to insert the obturator into the cannula it would not fit.That is when they noticed that plastic piece had partially popped out.That is all she could tell me." patient status - no contact with patient.Type of intervention - na.
Additional Manufacturer Narrative
Investigation summary: the event product was returned to applied medical for evaluation.Upon inspection, engineering noted that the seal returned appeared to be a 5 mm kii® seal, while the obturator and cannula were 8 mm products.Two components were dislodged on the obturator.Engineering was able to replicate the complainant's experience by attempting to insert a similar 8 mm obturator, which was not activated, into a similar 5 mm seal.The likely root cause of the component dislodgement is due to the attempted insertion of an 8 mm obturator into the 5 mm seal.It's possible that the 5 mm and 8 mm seals could have been mixed due to a line clearance issue during seal assembly.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: C0Q61,KII 8X100MM ZTHR SHLD BLD SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6049249
• Report Number: 2027111-2016-00719
• Device Sequence Number: 18922227
• Product Code: GCJ
• UDI-Device Identifier: 00607915116149
• UDI-Public: (01)00607915116149(17)190609(30)01(10)1269914
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 03/30/2017

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: 06/09/2019
• Device Model Number: C0Q61
• Device Catalogue Number: 101066001
• Device Lot Number: 1269914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1