MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Based on the description of the event, it is likely that the reported event was caused by an instrument.The instructions for use (ifu) states, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." 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.
Event or Problem Description
Procedure performed: "laparoscopic prostatectomy." event description: "valve fragmentation." report from the sales rep: during laparoscopic prostatectomy, the valve inside the trocar was fragmented at three sections.Two fragments matching the two missing sections were removed from abdominal cavity.However, the customer is not sure whether the rest of the fragments remained inside abdominal cavity or it was removed because of intraperitoneal irrigation.The sizes of the fragments were approx.1 mm.Cer check list is unavailable.Initial investigation report by aomori olympus the event unit was not returned to olympus.The incident will be informed amr of for further evaluation.(b)(4).This is a complaint from the market.(b)(4).Patient status: "no patient injury.".

• Brand Name: CFR73, 12X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6921274
• Report Number: 2027111-2017-02039
• Device Sequence Number: 10975653
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)200405(30)01(10)1293727
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• 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
• Report Date (Section B): 10/05/2017

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: 04/05/2020
• Device Model Number: CFR73
• Device Catalogue Number: 101245601
• Device Lot Number: 1293727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/06/2017
• Patient Sequence Number: 1