MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY AMERICA INC. KARL STORZ MONOPOLAR CORD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 26006M

Device Problems Fire (1245); Material Puncture/Hole (1504); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  Injury  

Event Description

When the device was activated, the team heard a loud "pop".The cord severed and then flipped onto the pt's drape on their leg.At this point a small flame was noted and a 5mm hole was discovered in the drape.The end was pulled from the field and immersed in water.Drapes were removed, pt examined with no injuries.

• Brand Name: KARL STORZ MONOPOLAR CORD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KARL STORZ ENDOSCOPY AMERICA INC.
• MDR Report Key: 14456293
• MDR Text Key: 292172869
• Report Number: MW5109797
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26006M
• Device Lot Number: XTQ1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White