OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A42011A |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
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Event Description
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Olympus was informed that during an unspecified hysteroscopic procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient¿s uterus.The procedure had to be abandoned and a follow-up procedure is to be scheduled to recover the broken off fragment.
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Manufacturer Narrative
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Device evaluation: despite the original announcement the suspect medical device was returned to the manufacturer for evaluation/investigation.Therefore, this case has been reopened and the physical device was investigated.The investigation confirmed that the ceramic insulation at the distal end of the resection sheath is broken off and is missing.In addition, slight dents were found on the insertion tube.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed from olympus side but, independently from the above mentioned issue, a capa was initiated in march 2019 where further investigations, trending, and surveillance will be performed.Furthermore, the user will be informed about the investigation results.
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Manufacturer Narrative
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Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation/investigation was performed exclusively on the basis of the information/photos provided by the customer.According to the photos provided, it could be confirmed that the ceramic insulation at the distal end of the resection sheath is broken off and is missing.This type of damage is typically caused by thermal and/or mechanical overload in combination with wear and tear.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert had already been pre-damaged, whether the damage was triggered during the reprocessing cycle preceding the incident, or during the last procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed from olympus side but, independently from the above mentioned issue, a capa was initiated in march 2019 where further investigations, trending, and surveillance will be performed.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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Event Description
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Olympus was informed that during an unspecified hysteroscopic procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient¿s uterus.The originally intended procedure had to be abandoned in order to retrieve the fragment, which was canceled after two hours without any success.A follow-up procedure may be scheduled depending on the patient condition.
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Search Alerts/Recalls
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