MAUDE Adverse Event Report: COOK INC CAPTURA HELICAL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G32727
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Pma/510(k) # - 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
The surgeon reported an adverse event that occurred in one of his lists in (b)(6) 2018.The hospital ordered a urology basket (product ce-432115) and the surgeon, an upper gi consultant, used it to remove stones in the common bile duct (cbd) causing 2 perforations to the patient¿s ducts.The surgeon closed the perforations successfully and no further patient complication arose as a consequence to these perforations.The surgeon commented that the basket was rigid and the sheath had some resistance due to its coating when it was passed down the olsen-reddick clamp (which is used commonly in laparoscopic cbd cases).The surgeon was informed they had used an urology product in error that was not intended or licensed for use in the cbd.The surgeon doesn¿t feel it¿s cook¿s fault or a fault of this product (it was used off license without them really realizing it was the case).Additional information was provided.This product was ordered for cbd stones because it is the recommended replacement for obsolete product (cef-545065), captura helical stone extractor, used for stone manipulation and removal in the urinary tract.The hospital has been using this basket regularly to remove stones in the cbd for over a decade.
Additional Manufacturer Narrative
Additional information provided in event.
Event or Problem Description
The following statement was provided on 16jan2019.Basket opened and closed fine.However, being a urology basket, it was suitable for the tissue in the common bile duct.It is a much firmer metal than the cook baskets indicated for the common bile duct.Inquiry was made to verify if this statement is accurate.Received response to inquiry on 24jan2019.There was a typing error.Response should have read "it wasn't suitable for the tissue of the common bile duct".
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation the complaint device was not returned for an evaluation.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and quality control data.The surgeon was contacted and advised they had used a urology product in error that was not intended or licensed for used in the cbd.The physician does not feel it's cook's fault or a fault of this product (since it was used off license without them really realizing it was the case).A review of the device history record found no non-conformances that would have caused or contributed to the reported event.A review of complaint history records revealed no additional complaints have been received on the complaint device lot.A review of the instructions for use (ifu), found no information in the ifu related to the device not being intended or licensed for used in the common bile duct (cbd).The information provided states the device was used to remove stones in the common bile duct.The captura helical stone extractor device was designed for stone manipulation and removal in the urinary tract.The device was not used for the correct application.The conclusion was determined to be cause traced to user; unintended use error caused or contributed to the event.The user is now aware of the correct application.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no additional risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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
There is no new event information to report.

• Brand Name: CAPTURA HELICAL 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: 8271042
• Report Number: 1820334-2019-00203
• Device Sequence Number: 13842209
• Product Code: FFL
• UDI-Device Identifier: 00827002327276
• UDI-Public: (01)00827002327276(17)210906(10)9143787
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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,Followup
• Report Date (Section B): 05/13/2019

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 Expiration Date: 09/06/2021
• Device Model Number: G32727
• Device Catalogue Number: CE-432115
• Device Lot Number: 9143787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019; 04/17/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 01/24/2019; 05/13/2019
• 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: Required Intervention
• Patient Age: 21 YR