MAUDE Adverse Event Report: COOK, INC. FLEXOR URETERAL ACCESS SHEATH AND DILATORS; ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY

Catalog Number FUS-095045

Device Problems Material Separation (1562); Delamination (2904)

Patient Problem Foreign body, removal of (2365)

Event Date 01/15/2015

Event Type  Injury  

Event Description

While preforming a dual approach pcnl, (percutaneous nephrolithotomy, with ureteroscopy), a piece of the coating sheared off.The physician used grasping forceps to remove the piece.No harm to the pt and no add'l procedures or intervention were required due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

During investigation, a review of complaint history, drawing, information for use (ifu), manufacturing instructions (mi), quality control (qc), specifications, trends and a visual inspection was conducted.The used sheath was returned for evaluation.It was not possible to evaluate the internal lining of the tubing without compromising the evaluation, so the complaint will be confirmed based on customer statements and the complaint history of the device.There were no visual signs of damage to the outside coating or the proximal adapter.The device is inspected to be free of debris and discoloration, surface of tubing must be free of kinks, bumps, cuts, broken coils, coil separation, protruding coils, exposed coils and/or the appearance of exposed coils, and coils must have an acceptable amount of coating.The coating is also visually inspected for excess or flaking.Based on the complaint history of the device, it is very likely the inner lining of the sheath was damaged by another instrument.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4527431
• MDR Text Key: 5358472
• Report Number: 1820334-2015-00067
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00827002461673
• UDI-Public: (01)00827002461673(17)171030(10)5403282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2017
• Device Catalogue Number: FUS-095045
• Device Lot Number: 5403282
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention