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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIVCO MEDICAL INSTRUMENTS CO., INC SURGI-TIP TRANSDUCER COVER ULTRASOUND TRANSDUCER COVER

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CIVCO MEDICAL INSTRUMENTS CO., INC SURGI-TIP TRANSDUCER COVER ULTRASOUND TRANSDUCER COVER Back to Search Results
Model Number 610-833
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2016
Event Type  malfunction  
Manufacturer Narrative
The actual product was not available for review by civco. Ten covers from the same lot and box were returned from the facility and all were tested for leaks and tears under simulated conditions. No samples tore or leaked under simulated usage. We have reviewed the incoming inspection records for the components used in the cover assembly and there were no anomalies noted in the dhr. Additionally, the manufacturing records for the lot in question were also reviewed. All records show the product has passed all incoming and in-process inspection and evaluations. We have been unable to obtain further information from the user at this time to determine if there were any external opportunity for the cover and probe to contact a sharp instrument or object which could cause the cover to tear when it is under tension. This is a re-submission of the report conducted on 7/28/2016. Original submission had incorrect facility identification number and was rejected. Failed device was not returned.
 
Event Description
Civco was notified on (b)(4) 2016 by the user facility of a cover ripping during a laminoplaty producture and contaminated the sterile field. Customer stated the covers were held in a temperature controlled cabinet and would be sending back 10 samples for review. On 7/20/2016 civco received a copy of the report submitted by the customer further detailing the event that a chile was undergoing a laminoplasty procedure. After initial first incision, the transducer cover was used in the sterile procedure to cover the ultrasound probe. Once the ultrasound probe with cover was placed on ther sterile field, the rubber part of the cover broke. The probe was identified to be non-sterile and was in the surgical site. The doctor stopped the procedure, took a cultor of the wound, and vancomycin powder was placed on the incision. The incision was closed. The doctor had not entered the dura at the time the breach was discovered. The patient was discharged with antibiotics and is to return in 3-4 weeks for laminoplasty.
 
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Brand NameSURGI-TIP TRANSDUCER COVER
Type of DeviceULTRASOUND TRANSDUCER COVER
Manufacturer (Section D)
CIVCO MEDICAL INSTRUMENTS CO., INC
102 first street south
kalona IA 52247
Manufacturer (Section G)
CIVCO MEDICAL INSTRUMENTS CO., INC.
102 first street south
kalona IA 52247
Manufacturer Contact
james leong
2301 jones blvd
coralville, IA 52241
3192486502
MDR Report Key6543746
MDR Text Key74702450
Report Number1937223-2016-00001
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013721
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2019
Device Model Number610-833
Device Catalogue Number610-833
Device Lot NumberM941840
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/04/2017 Patient Sequence Number: 1
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