MAUDE Adverse Event Report: CIVCO MEDICAL INSTRUMENTS CO., INC. SURGI TRANSDUCER COVER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Hole In Material (1293)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/22/2015

Event Type  malfunction  

Event Description

When the surgical case was finished, staff discovered there was a hole in the neoprobe cover because the neoprobe was bloody.

• Brand Name: SURGI TRANSDUCER COVER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): CIVCO MEDICAL INSTRUMENTS CO., INC.; 102 first st. south; kalona IA 52247
• MDR Report Key: 5031076
• MDR Text Key: 24088387
• Report Number: 5031076
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/04/2015,08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 59 YR