MAUDE Adverse Event Report: KARL STORZ ENDOVISION KARL STORZ; LIGHT SOURCE

Model Number 201331-20-1

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2014

Event Type  malfunction  

Event Description

Allegedly, during preparation for a laparoscopic procedure, the operating room staff set the light source to standby and laid the scope with light cable attached on the patient drape covering the patient.They plugged in the light cable to the light source and noticed shortly thereafter that a small hole was burned in the patient drape.The light source had switched off from standby to a higher intensity and device burned a hole in the drape.The device was taken off the patient drape and patient checked; there was no impact on patient.Light source replaced and procedure completed.

Manufacturer Narrative

Attenuator stepper motor was not functioning properly, motor was getting stuck due to malfunction of a component on the control board.

• Brand Name: KARL STORZ
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ ENDOVISION; charlton MA
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill rd.; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 3739029
• MDR Text Key: 14880587
• Report Number: 1221826-2014-00009
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/07/2014

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
• Device Operator: Health Professional
• Device Model Number: 201331-20-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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): Required Intervention