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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS INC. ENDO SMARTCAP; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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MEDIVATORS INC. ENDO SMARTCAP; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 100145CO2EXT
Device Problems Device Difficult to Setup or Prepare (1487); Failure of Device to Self-Test (2937)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2022
Event Type  malfunction  
Event Description
Tubing connected to endostratus co2 insufflator and scope.Tubing would not "pre-test" appropriately.Disconnected all connections to scope and endostratus co2 insufflator multiple times, still would not deliver c02 bubbles prior to first procedure of the day.Tubing changed and functioned appropriately.No patient harm.Manufacturer response for endoscopy tubing, endo smartcap (per site reporter).Equipment failure reported to customer services via e-mail.Equipment returned to manufacture for investigation.
 
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Brand Name
ENDO SMARTCAP
Type of Device
CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
MEDIVATORS INC.
3150 pollok drive
conroe TX 77303
MDR Report Key15437120
MDR Text Key300044637
Report Number15437120
Device Sequence Number1
Product Code FAJ
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 09/08/2022,08/26/2022
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 Model Number100145CO2EXT
Device Catalogue Number100145CO2EXT
Device Lot Number550001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2022
Event Location Hospital
Date Report to Manufacturer09/16/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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