On (b)(6) 2019, dr.(b)(6) reports in an email: "i was handed a trocar that had less of a curve and i punctured the bladder." surgeon and sales rep were contacted for further information.On 08/13/2019, sales rep provides additional information: "i met with her and she said the wrong trocar was brought into the or.I am going tomorrow to meet with her or nurse to look over all trocars they have and figure out which one was brought in.She said she believed the instrument handle ended in a "30".Surgeon kept trying to find the case, patient and all that info and couldn't find it and said she'd have to look into it further for me.She said she remembered the trocar instrument ending in 30 not 32 though.She unfortunately didn't have much prepared for me or much information.She said it was early this year and she had finally just got around to contacting us about it.All she could tell me: she was doing transvaginal and the trocars looked almost identical, but she noticed the handle seemed different.She thought maybe they gave her the suprapubic instrument vs transvaginal.".
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Two cal-tv30 instruments have been received at coroporate (lot # 46594) for investigation.Per engineering analysis both instruments of cal-tv30 passed tip inspectiont test and are considered to be within specification according to drawing 02-231 for tip dimensioning.Concluding this engineering analysis, the returned instruments demonstrate mechanical deformity due to apparent modification when measured to the device drawing and specifications.It appears that the instruments were equally modified, which affected the functionality of the instruments.Modification of instruments is contraindicated in the warnings section of the indications for use (ifu), #10-193.The disposition of these instruments is quarantined and not available for future use.
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