OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS "HIQ+", 5 X 330 MM, FLAT, ERGO, DEACTIVATABLE RATCHET; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
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Model Number WA63032A |
Device Problems
Arcing (2583); Sparking (2595)
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Patient Problems
Burn(s) (1757); Necrosis (1971)
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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 therapeutic laparoscopic procedure at an unknown date the patient sustained burn necrosis at the trocar incision.No further information was provided.
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Manufacturer Narrative
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The suspect medical device was not 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.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Instead a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.
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Search Alerts/Recalls
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