MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number	C0R50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
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 the investigation.This report is to follow-up medwatch report #mw5071471.
Event or Problem Description
Procedure performed: "robotic-assist bilateral inguinal hernia repair with mesh, right ischial bone biopsy" event description: this report was received via mail from the fda medwatch # mw5071471."during procedure instrument tip broke off device.Retrieved and no harm to pt." type of intervention: retrieved patient status: no harm to pt.
Additional Manufacturer Narrative
Correction: therapy date was changed from (b)(6) 2017 to (b)(6) 2017.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 force applied during the procedure in combination with lipid exposure on the tip of the cannula.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.This report is to follow-up medwatch report #mw5071471.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6884330
• Report Number: 2027111-2017-01984
• Device Sequence Number: 16446039
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)200224(30)01(10)1290316
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060629
• 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): 11/01/2017

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: 02/24/2020
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1290316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 11/01/2017
• Patient Sequence Number: 1