MAUDE Adverse Event Report: GYRUS ACMI DOLPHIN II TRANSDUCER; TRANSDUCER TUBING

Catalog Number DOL-TUB

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

Event Description

When hooking up equipment at the start of the surgical case, the dolphin device reads "bad transducer." the doctor commented that there have been too many events like this lately.Events have been occurring over a three month time period.No injury to the patient.

• Brand Name: DOLPHIN II TRANSDUCER
• Type of Device: TRANSDUCER TUBING
• Manufacturer (Section D): GYRUS ACMI; 136 turnpike road; southborough MA 01772
• MDR Report Key: 5350176
• MDR Text Key: 35237803
• Report Number: 5350176
• Device Sequence Number: 1
• Product Code: HIG
• 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
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/09/2017
• Device Catalogue Number: DOL-TUB
• Device Lot Number: S146536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR