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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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APPLIED MEDICAL RESOURCES CORPORATION KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number CTF33
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2017
Event Type  malfunction  
Event Description
The 11mm applied medical trocar ref#ctf33 shaft bent on inserting into patient.
 
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Brand Name
KII FIOS FIRST ENTRY
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES CORPORATION
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key6852099
MDR Text Key85374849
Report Number6852099
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/20/2017,07/31/2017
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
Device Operator Physician
Device Expiration Date12/05/2019
Device Model NumberCTF33
Device Lot Number1284581
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/20/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/08/2017
Type of Device Usage N
Patient Sequence Number1
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