MAUDE Adverse Event Report: KARL STORZ ENDOVISION LIGHT SOURCE, 300 WATT XENON W/SCB

Model Number 201331-20-1

Device Problem Use of Device Problem (1670)

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

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

The light source was returned and evaluated; our findings were as follows: all output readings are below spec. Unit was received in with a different lamp installed than what our records show we installed when we last serviced the light source in july 2016; also, the lamp differs from what karl storz recommends. Lamp output is not meeting spec. Lumen reading: 1113 actual; spec rating 1530-2800. Optical power 1. 9 actual; spec rating 5. 1 max. In addition, the model numbers for the light cable and arthroscope used for the procedure, which were provided to us by the hospital, are not of our manufacturer; the light cable, model #wa03310a, we believe is an olympus light cable; the arthroscope, model #502104030, is a stryker model number. There was no reported malfunction of the light source. The burn injury most likely occurred as a result of the light cable's connector coming into contact with the patient.

Event Description

Allegedly, the patient sustained a 3rd degree burn under her arm during a rotator cuff arthroscopy procedure; the burn was noticed by the patient the day after the procedure.

• Brand Name: LIGHT SOURCE, 300 WATT XENON W/SCB
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7986369
• MDR Text Key: 124476851
• Report Number: 1221826-2018-00082
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 201331-20-1
• Device Catalogue Number: 201331-20-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/19/2018 Patient Sequence Number: 1