OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number A22201C |
Device Problems
Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical devices have not yet been returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical devices are 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 transurethral resection (tur) procedure, the loop wires of three different hf resection electrodes broke off and fell inside the patient.While two loop wires were retrieved from the patient by an unknown approach, there is a possibility that the third loop wire remained inside the patient as it could not be found.The intended procedure was successfully completed with another hf resection electrode and there was no adverse event or patient injury.This is report 2 out of 3.
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Manufacturer Narrative
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Three hf resection electrodes from the same model and lot were returned to the manufacturer for evaluation/investigation.All of the hf resection electrodes are unused, in their original, sterile packaging.Olympus america inc.("oai") is implementing a removal action of specified lot numbers of the monopolar hf resection electrodes a22201c and wa22037c.The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.Oai has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes.Investigations have confirmed that loop wires can break during the intended use of the electrodes.As a result, a fragment may fall inside the patient and will need to be retrieved.Retrieval of the fragment could prolong the procedure and, under certain circumstances, could require additional surgical treatment.The investigation revealed that the loop wires of the affected electrodes were damaged during production.The cause of this damage is defective manufacturing equipment.The damaged loop wires cannot be detected by visual inspection.There has been no report to date of an adverse event or patient injury.However, in an effort to prevent a potential risk to patient health, oai is undertaking this action to remove the affected lot numbers.Oai's correction number according to 21 cfr 806.10 (c) (1): 2429304-4/18/2017-044r.
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