MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. HERCULES UNIVERSAL STABILIZER ARM; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number 401-152T

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Estech instrument broke during the case.Used to hold the heart intraoperatively.Broke during case - was retrieved by surgeon and taken off the field.No patient harm.No retained objects confirmed by x-ray.The instrument fell apart while putting together, while tightening up.Surgeon stated the cable snapped.Confirmed all pieces were present - broke in large pieces.(b)(4) sold the stabilizing arm to (b)(4).Waiting on a quote from representative for replacement.

• Brand Name: HERCULES UNIVERSAL STABILIZER ARM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10294761
• MDR Text Key: 199484572
• Report Number: 10294761
• 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
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 401-152T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA