MAUDE Adverse Event Report: AESCULAP INSULATED OUTER TUBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PM973R

Device Problem Crack (1135)

Patient Problem Skin Discoloration (2074)

Event Date 12/23/2020

Event Type  malfunction  

Event Description

Surgeon was performing a robotic assisted laparoscopic hysterectomy and bso.He began using a monopolar scissor with cautery to cut an adhesion.He noticed a slightly blackened area above where he was operating and began to question where it came from.It was removed from the sterile field and tagged for repair to be sent through the vets office in a biohazard bag.The scrub tech, who stated that it appeared that the insulation was cracked and that it caused the blackened area.A ligasure was then opened to continue the dissection, at surgeon's request.

• Brand Name: INSULATED OUTER TUBE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11372048
• MDR Text Key: 233276810
• Report Number: 11372048
• 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: 01/29/2021

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: PM973R
• Device Catalogue Number: PM973R
• 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: 01/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA