MAUDE Adverse Event Report: KARL STORZ SE & CO. KG D-LIGHT P HIGH POWER LIGHT UNIT FOR AF; LIGHT SOURCE

Model Number	20133720-1
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no report of a device malfunction and the subject device is not being returned for evaluation.The most likely cause of the burn to patient was that the tip of the scope was occluded, causing the scope tip to overheat.
Event or Problem Description
Allegedly, during a lap chole procedure, while they were using fluoroscopy, the laparoscope was pulled back and the tip of the scope was rested inside of the trocar cannula (the scope was connected to an active light cable that was plugged into the d-light p high power light source; this resulted in the patient being burned at the umbilicus trocar entrance site.The burn was noticed after the procedure.We have been unable to obtain any further details about the patient or the event.

• Brand Name: D-LIGHT P HIGH POWER LIGHT UNIT FOR AF
• Common Device Name: LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9153838
• Report Number: 9610617-2019-00093
• Device Sequence Number: 16683694
• Product Code: OWN
• UDI-Device Identifier: 04048551004685
• UDI-Public: 4048551004685
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K152583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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
• Operator of Device: Health Professional
• Device Model Number: 20133720-1
• Device Catalogue Number: 20133720-1
• Was Device Available for Evaluation?: No
• Device Age: 5 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other