MAUDE Adverse Event Report: AESCULAP AG AESCULAP; RETRACTOR

Model Number FB805R

Device Problem Difficult to Open or Close (2921)

Patient Problem Blood Loss (2597)

Event Date 11/29/2020

Event Type  malfunction  

Event Description

Chest retractor would not open, or close once placed inside patient.Surgeon was unable to open the chest more with this retractor.This was a significant problem because there was a major bleed of the pulmonary artery, and the surgeon was unable to fully get his hand in the wound to sew.It was a life or death situation, and the outcome was unknown for approximately 15 minutes.It was traumatic for all parties involved.

• Brand Name: AESCULAP
• Type of Device: RETRACTOR
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 10991472
• MDR Text Key: 220990796
• Report Number: 10991472
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2020

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?: Yes
• Device Operator: Other
• Device Model Number: FB805R
• Device Catalogue Number: FB805R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA