MAUDE Adverse Event Report: KARL STORZ KARL STORZ ADAPTER/ LIGHT CORD; URETEROSCOPE AND SCCESSORIES

Model Number 496 U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/16/2018

Event Type  No Answer Provided  

Event Description

Left 7 french ureteral guide lighted catheter was placed before the procedure started.The device was a karl storz lighted stent with adapter and light cord.Patient was in a low lithotomy procedure and at the end of the case after removing the drapes, the operating room team found a small blister on the patient's buttock from the light cord and/or the adapter that was used to attach the catheter to the light cord.Physician documented small blister on the post op record and light cord burn.This was a demo unit and the sales rep, michael johnson was present during the insertion but not present for the case.Here is the equipment that was involved in the case: storz-d-light p 20133720 sn (b)(4), xeon nova 175 20131520 sn (b)(4), storz foot pedal model 20014130 sn (b)(4), adapter karl storz 496u lot ts 09.Reported to sales rep on (b)(6) 2018.

• Brand Name: KARL STORZ ADAPTER/ LIGHT CORD
• Type of Device: URETEROSCOPE AND SCCESSORIES
• Manufacturer (Section D): KARL STORZ; GM
• MDR Report Key: 7365863
• MDR Text Key: 103519965
• Report Number: MW5076041
• Device Sequence Number: 0
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Device Operator: Health Professional
• Device Model Number: 496 U
• Device Lot Number: LOT TS 09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 85