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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII® BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL PLASTIC SURGERY

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APPLIED MEDICAL RESOURCES CORPORATION KII® BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number C0R50
Device Problems Seal (432); Material Puncture/Hole (1504); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2018
Event Type  Malfunction  
Event Description

Air seal leak detected. Hole found in balloon.

 
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Brand NameKII® BALLOON BLUNT TIP SYSTEM
Type of DeviceLAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES CORPORATION
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key8288266
MDR Text Key134457560
Report Number8288266
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/10/2019,12/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0R50
Device Catalogue NumberCOR50
Device LOT Number1320368
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2019
Event Location Hospital
Date Report TO Manufacturer01/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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