MAUDE Adverse Event Report: APPLIED MEDICAL C7302, 5MMX33CM EPIX L-HOOK ES PRB 1/EA; GEI

Model Number	C7302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Nephrectomy - "the thread of probe connector is broken in surgery suddenly.Please consult with attached photo." patient status - "fine".
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon inspection, engineering found cracks and interior damage.A review of the manufacturing records for the lot number provided reveal that the product passed all quality and manufacturing inspections.The root cause is most likely the non-qualified sterilization methods mentioned in the customer's additional information.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Nephrectomy - "the thread of probe connector is broken in surgery suddenly." patient status - "fine.".

• Brand Name: C7302, 5MMX33CM EPIX L-HOOK ES PRB 1/EA
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5620073
• Report Number: 2027111-2016-00298
• Device Sequence Number: 87841
• Product Code: GEI
• UDI-Device Identifier: 00607915127640
• UDI-Public: (01)00607915127640(17)190919(30)01(10)1231442
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2017

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: 09/19/2019
• Device Model Number: C7302
• Device Catalogue Number: 101147301
• Device Lot Number: 1231442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1