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

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.

• Brand Name: SURGI-TIP TRANSDUCER COVER
• Type of Device: ULTRASOUND 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 Key: 6543746
• MDR Text Key: 74702450
• Report Number: 1937223-2016-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013721
• Number of Events Reported: 1
• 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 Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2019
• Device Model Number: 610-833
• Device Catalogue Number: 610-833
• Device Lot Number: M941840
• 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 Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• 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