Model Number 900-151 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
|
|
Event Description
|
Per customer's statement via fax message - "yesterday while performing a leep, the above noted biopsy tip was found to have broken its tip off into patient's cervix.It was removed while removing an iud after procedure to dislodge the tip".(b)(4).
|
|
Manufacturer Narrative
|
Reference: (b)(4).Investigation: x-initiated manufacturer's investigation.X-no sample returned.Analysis and findings: distribution history.Distribution history could not be determined as lot number was not provided with the complaint.Manufacturing record review: a review of the lot dhr was not performed as no lot number was provided.Incoming inspection review: a review of the incoming inspection record could not be performed as the record had been archived and not available at the time of this investigation.Service history record : service history record not applicable to this product.Historical complaint review: a review of the product two-year history indicated did not reveal any trends related to the description of the reported event.The reported event will be monitored for possible future reported event trending.Product receipt: the sample was not returned at the time of this investigation.Visual evaluation: the sample was not returned at the time of this investigation and thus evaluation was not performed.Functional evaluation: functional evaluation is not applicable to this complaint.Root cause: definitive root cause is indeterminable however, previous testing performed in 2011 in trying to replicate reported events of the wire "burning" or "snapping" indicated the product performed as intended, the testing was repeated in march of 2019 and resulted in the same manner.Correction and/or corrective action: coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time, as the complaint condition was not confirmed.None.No further training required at this time.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
|
|
Event Description
|
Per customer's statement via fax message - "yesterday while performing a leep, the above noted biopsy tip was found to have broken its tip off into patient's cervix.It was removed while removing an iud after procedure to dislodge the tip".Ref: (b)(4).
|
|
Search Alerts/Recalls
|