MAUDE Adverse Event Report: COOK INC ATLAS-WIRE STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G32824
Medical Device Problem Codes	Material Separation (1562); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: olympus flexible ureteroscope with 3.6fr working channel.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported during a flexible ureteroscopy with laser lithotripsy through a flexor ureteral access sheath using an atlas-wire stone extractor, part of the basket broke off.The physician was able to retrieve the basket fragment during the procedure.Other extractors malfunctioned, and would not open, in the same case (these incidents are reported under files containing the following patient identifiers:(b)(6)).The physician reported it was a long case with a lot of stone, and the "extractors eventually failed after several passes," with only one of the complaint devices malfunctioning upon removing it from the package.The procedure was completed with another cook extractor and with "careful perseverance".No adverse effects to the patient have been reported as a result of this alleged product malfunction.
Additional Manufacturer Narrative
H3: investigation is currently in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was initially reported that during a flexible ureteroscopy with laser lithotripsy through a flexor ureteral access sheath, multiple cook extractor devices malfunctioned and would not open, including one device separating (reported under patient identifiers (b)(6)).Ultimately, the procedure was successfully completed with another cook extractor device.Five (5) devices were returned to the manufacturer.Upon completion of the device failure analysis forms on 02jul2019 the following information has been provided: two (2) ncircle tipless stone extractor devices were returned.The first device, (reported under patient identifier (b)(6)) was noted to malfunction in terms of not opening and closing properly.The second device (reported under patient identifier 270371) was noted to be "severed" or separated.Three (3) atlas-wire stone extractor devices were returned.During the investigation, it was discovered that all three of these devices were noted to malfunction in terms of not opening and closing properly.It was initially reported that two of the atlas-wire stone extractor devices malfunctioned in terms of not opening and closing properly and were mistakenly reported (reported under patient identifier (b)(6)).It was also initially reported that one of the atlas-wire stone extractor devices separated (reference this report), but it has been confirmed that this was mistakenly reported as well, as the separated extractor device was the ncircle tipless stone extractor (reported under patient identifier (b)(6)).As it was mistakenly reported that one of the atlas-wire stone extractor devices separated, no additional follow up mdr will not be submitted under patient identifier (b)(6).

• Brand Name: ATLAS-WIRE STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8759749
• Report Number: 1820334-2019-01609
• Device Sequence Number: 13963137
• Product Code: FFL
• UDI-Device Identifier: 00827002328242
• UDI-Public: (01)00827002328242(17)210427(10)8846608
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: G32824
• Device Catalogue Number: AE-432115
• Device Lot Number: 8846608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO B5
• Patient Age: 60 YR