MAUDE Adverse Event Report: GYRUS ACMI, INC. DOLPHIN II; INSUFFLATOR, HYSTEROSCOPIC

Model Number DOL-2

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 04/23/2014

Event Type  No Answer Provided  

Event Description

Fluid management system was reported to have the "door unable to open when bag needed to be changed".Biomed was unable to reproduce a problem with the unit.No disposables were saved for inspection.Is it possible that if the bag is not empty, or the set is defective, that it will result in resistance to the door opening?.

• Brand Name: DOLPHIN II
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 4168904
• MDR Text Key: 4870170
• Report Number: 4168904
• Device Sequence Number: 1
• Product Code: HIG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/16/2014

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?: *
• Device Operator: Unknown
• Device Model Number: DOL-2
• Device Lot Number: D06A005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1