MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH OLYMPUS HF CABLES

Model Number A0393

Device Problem Sparking (2595)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 06/30/2015

Event Type  Injury  

Event Description

Olympus was informed that at the start of a transurethral resection of the prostate (turp) procedure, the device sparked and burned through the scrubs and gown of a surgical technician.The surgical technician received 3rd degree burns on his leg.The burn was treated.There was no harm to the patient.The procedure was successfully completed using a different but similar device.The surgical technician is reportedly doing well.Additionally, the device was less than a year old.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

• Brand Name: OLYMPUS HF CABLES
• Type of Device: HF CABLE
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH; kuehnstrabe 61, 2045; hamburg, ; GM
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4921929
• MDR Text Key: 6434852
• Report Number: 2951238-2015-00308
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0393
• Device Catalogue Number: A0393
• Device Lot Number: 236668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention