Model Number 20132620-1 |
Device Problems
Off-Label Use (1494); Unexpected Shutdown (4019)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/26/2023 |
Event Type
malfunction
|
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 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.
|
|
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).
|
|
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).
|
|
Search Alerts/Recalls
|