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: Health Professional
• 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
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 58