• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR33, 11X100 KII OPT ZTHR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APPLIED MEDICAL RESOURCES CTR33, 11X100 KII OPT ZTHR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CTR33
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  Malfunction  
Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation. A follow-up report will be sent upon completion of investigation.

 
Event Description

Procedure performed: uterine fibroid surgery. Event description: in preparation for the surgery, plastic was broken at the connection area to check and replaced new ctr33 and completed operations. Intervention: replaced new ctr33 and completed operations patient status: no patient injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCTR33, 11X100 KII OPT ZTHR 6/BX
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
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 Key10483031
MDR Text Key205307716
Report Number2027111-2020-00543
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK060096
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCTR33
Device Catalogue Number101219801
Device LOT Number1366694
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-