MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. RETRACTOR; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 401-1610

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

Event Description

The estech retractor (cat# 401-1610; serial number (b)(4)) fell apart while being used for the procedure.A chest x-ray was taken at approximately 4:30 am and report received at 5:56 am; report was negative.

Event Description

The estech retractor (cat# 401-1610 serial number (b)(4)) fell apart while being used for the procedure.A chest x-ray was taken at approximately 4:30 am and report received at 5:56 am; report was negative.

• Brand Name: RETRACTOR
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 7555 innovation way; mason OH 45040
• MDR Report Key: 8458941
• MDR Text Key: 140140738
• Report Number: 8458941
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 401-1610
• Device Catalogue Number: 401-1610
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA