MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COLD LIGHT FOUNTAIN XENON 100 SCB

Model Number	20132620-1
Medical Device Problem Codes	Off-Label Use (1494); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the lamp was used in a veterinary laparoscopic spay operation of a dog.After the lamp failed, the operation was turned in an open surgery, so it turns also from an ovariectomy to an ovariohysterectomy.The ifu stated that it is only allowed to use the device in human medical application (especially gastroenterology).In addition, no event (timeframe: between 2021-06-28 and 2023-07-11) that could be considered as similar to this one and caused or contributed to a death or serious injury could be found.Although the instrument was used off-label the case deemed reportable because the case had to be converted to an open surgery due to the loss of light, which could also happen during human application.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
During the product inspection of the returned light source, it was found that the lamp does not start because the glass body of the lamp is broken.The bulb holder has broken out of the socket and is moving freely on the underside of the housing.Scratch marks can be seen on the underside of the housing, indicating that the bulb must have broken off over a longer period of time.After replacing the xenon lamp, the light source worked perfectly again.The device has not been repaired at karl storz since it was delivered to the customer in december 2014.Based on the given facts, the most probable cause is wear and tear.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COLD LIGHT FOUNTAIN XENON 100 SCB
• Common Device Name: COLD LIGHT FOUNTAIN XENON 100 SCB
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave.; el segundo, CA 90245
• MDR Report Key: 17326741
• Report Number: 9610617-2023-00158
• Device Sequence Number: 17733914
• Product Code: GCT
• UDI-Device Identifier: 04048551062838
• UDI-Public: 4048551062838
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2023

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: 20132620-1
• Device Catalogue Number: 20132620-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 10/31/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/11/2023; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown