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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX GCJ
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APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX GCJ Back to Search Results
Model Number CTB73
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2017
Event Type  Malfunction  
Manufacturer Narrative

The event device is anticipated to return. A follow-up report will be provided upon completion of the investigation.

 
Event Description

Procedure performed: unknown. Event description: "doctor stated that the blade did not retract". Additional information received from territory manager, on 03-oct-2017 at 6:37pm: "according to the surgeon the blade was exposed after insertion". Type of intervention: unknown. Patient status: "no patient injury".

 
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Brand NameCTB73, 12X100 KII SH BLD ZTHR 6/BX
Type of DeviceGCJ
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key6950185
MDR Text Key90303533
Report Number2027111-2017-02066
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCTB73
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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