Catalog Number J-SSG-554086 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It was reported, during a hydrotubation, the operator inserted the selective salpingography catheter into the 22° hysteroscope by hand.The catheter could not move forward after it was inserted about 2 centimeters (cm).The operator withdrew the catheter and found the end tip of the catheter was broken off.Requests were made for additional information regarding further details of the event, however, the customer has not provided any further information.No adverse events have been reported as a result of the alleged malfunction.
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Event Description
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Additional information was received 22aug2018: another new device was used to complete the procedure.The patient did not experience any adverse effect(s) due to this issue.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The length of the catheter is 39.4 cm in length.A visual examination noted the returned catheter displayed a waviness throughout the catheter.The catheter was found to be flattened approximately 1.5 cm from the distal tip.A stock.038¿ wire guide was passed completely through the catheter.The distal tip measured approximately 4 mm and was noted to be damaged.The device history record review showed there were no non-conformances associated with the reported failure.A search of complaint records revealed this is the only complaint for complaint device lot number 8001113.A review of the current versions of manufacturing instructions and quality inspection documents for this device was done.The complaint device was inspected by quality control per current specification.There is no evidence that suggests that this complaint device was manufactured out of specification.Investigators found that the catheter was flattened near the distal tip and the distal tip was noted to be damaged.A wire guide was still able to be passed all the way through the catheter.The cause for this specific failure mode is not able to be established at this time.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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There has been no new information received since the last report was submitted.
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Search Alerts/Recalls
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