MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
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 sent upon completion of investigation.
Event or Problem Description
Product procedure: unknown.Event description: "this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Cannula tip fragmentation.Report from the sales rep.The customer noted at the end of the surgery, the cannula tip was fragmented inside the abdominal cavity.The fragment was removed from patient, but it is possible that all pieces are not accounted for.During intraperitoneal irrigation, any fragments were not confirmed.The surgery was successfully completed without replacing the event unit.The customer recognized heat or force from an instrument was applied to the cannula tip.Please determine the root cause and which the cannula tip damage came from heat or force from an instrument.Initial investigation report: the event unit was returned to us and visually inspected.The cannula tip was fragmented and melted(pic.1).The returned fragment(pic.2) is similar to the missing section on the cannula in shape(pic.3).The unit will be returned to amr for further evaluation.(b)(4).One seal, cannula, fragment returning.Please see component list." type of intervention: the fragment was removed from patient.The surgery was successfully completed without replacing the event unit.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with a blue fragment.Visual inspection confirmed the complainant's experience of a fractured cannula tip.It was noticed that part of the blue fragment was melted/deformed.Based on the condition of the returned unit and the description of the event, it is likely that the tip fracture was caused by an instrument that was not fully closed before it was removed from the trocar.The damage to the fragment suggests that an energy instrument made contact with the tip of the cannula, which caused it to melt/deform.The probability and criticality of harm resulting from these failure modes 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: CTR03, 5X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7743154
• Report Number: 2027111-2018-00257
• Device Sequence Number: 13611667
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)210116(30)01(10)1315319
• Combination Product (Y/N): N
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 01/16/2021
• Device Model Number: CTR03
• Device Catalogue Number: 101138201
• Device Lot Number: 1315319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1