MAUDE Adverse Event Report: COOK INC FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH; GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Nit was reported that the physician performed nephroureterectomy and laser lithotripsy procedures on a patient by using flexor 180 deflecting ureteral access sheath and vueoptic 150cm fiber optic bundle devices together.During the sheath advancement, the physician noticed the ureter was perforated due to larger outer lumen of the flexor 180 deflecting ureteral access sheath and lack of appropriate flexion.No section of the device remained inside the patient¿s body.The physician was unable to complete the procedure.A stent and additional stone procedure was scheduled for the patient.This med watch report is for flexor 180 deflecting ureteral access sheath.Please see mdr # 1820334-2017-00835 for the second device (vueoptic 150cm fiber optic bundle) used on this patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use, and specifications was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.The device was shipped with the instructions for use (ifu), which provides numerous steps on proper procedures during use to ensure performance of the device."precautions - in the event of resistance, do not force the deflecting mechanism." review of the 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 investigation evaluation, the actual root cause is unknown and no conclusion can be drawn.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH
• Common Device Name: GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6537427
• Report Number: 1820334-2017-00809
• Device Sequence Number: 13863394
• Product Code: GCJ
• UDI-Device Identifier: 00827002509740
• UDI-Public: (01)00827002509740(17)171001(10)5310728
• Combination Product (Y/N): N
• Initial Reporter Country: BC
• PMA/510(K) Number: K072521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: FVAS-090075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other