MAUDE Adverse Event Report: AESCULAP AG AESCULAP BIPOLAR COAGULATION UNIT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number GN060

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2021

Event Type  malfunction  

Event Description

Refurbished unit with new type of foot pedal placed in or the day before.The foot pedal would only activate the unit intermittently.Neuro lead and biomed called to room to trouble shoot.Surgeon continued to have issues with foot pedal activation.The only other malis bipolar unit was brought to room and set up by neuro lead but the other foot pedal routinely used could not be located.Surgeon could not substitute with any other type of cautery and had to finish case with malfunctioning unit.

• Brand Name: AESCULAP BIPOLAR COAGULATION UNIT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 11444286
• MDR Text Key: 238616713
• Report Number: 11444286
• Device Sequence Number: 1
• Product Code: GEI
• 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: 03/03/2021

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: Health Professional
• Device Model Number: GN060
• Device Catalogue Number: GN060
• 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: 03/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA