COOK INC ROUND TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
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Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Event Description
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It was reported that at the end of a ureterorenoscopy procedure, when the physician removed the catheter, it was noted the catheter had a piece of the length ¿cut off¿ and was indwell in the ureteral of the patient.A ureteroscope and forceps were used to remove the fragment.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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(b)(4).Investigation - evaluation a review of the dimensional verification, documentation, functional test and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported: the device was returned in two segments.Catheter separated 3cm from the distal tip; separation occurred at the third ink band within the first sideport.Visual appearance of point of separation was ragged and showed signs of being cut and pulled to separation.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, the device was most likely cut during use.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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Event Description
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It was reported that at the end of a ureterorenoscopy procedure, when the physician removed the catheter, it was noted the catheter had a piece of the length ¿cut off¿ and was indwell in the ureteral of the patient.A ureterosope and forceps were used to remove the fragment.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
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