Investigation.Initiated manufacturer's investigation.No sample returned.Review dhr.Inspect returned samples.Inspect stock product.Analysis and findings.The affected device sample from the reported event has not been returned to date for proper investigative analysis.However, if the affected device is returned and made available in the future for analysis, the complaint may be reopened and addressed as needed.Although not definitive due to the absence of the affected sample, the reported event may be possible if excessive lateral force was applied thus enabling the metal support rod to penetrate the rumi tip.This may occur when the rod is in an acute angle in relation to the rumi tip with excessive force lateral applied, pushing against the rumi tip wall from the inside - outward.Although not confirmed in this case that the rumi tip was improperly attached, the rumitips-dfu instructs the user on how to properly attach the rumi tip to the handle.A review of the two-year product complaint history indicated two other complaints similar in nature and was concluded the result of this incident was likely attributed to improper loading, and or excessive or improper manipulation force by the end user (refer to (b)(4)).Also, the reporting account has had three past reported complaints, citing compromised tubing and balloon that resulted in leaks, this may also be another indication of possible improper handling, and or use.A review of the lot dhr did not reveal any abnormalities, review of inventory indicated that there is no stock available for work order (b)(4).Correction and/or corrective action corrective action is not applicable as it is highly likely that this event was caused by improper use.All uterine manipulator products are 100% visually and functionally verified to be acceptable during manufacturing assembly.
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