MAUDE Adverse Event Report: COOK INC WITTICH NITINOL STONE BASKET; LQR DISLODGER, STONE BILIARY

Model Number	G05877
Medical Device Problem Codes	Material Separation (1562); Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 was reported a wittich nitinol stone basket separated at the hub, proximal end, upon insertion into biliary track for stone removal.It is unknown if resistance was felt while inserting the device, however, no device components were retained by the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Correction: fitting problem (2183) is not labeled.Method code: (10) testing of actual/suspected device.Results code: (4247) appropriate term/code not available.Conclusion code: (11) conclusion not yet available.Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a dimensional verification and a visual inspection of the returned device were conducted during the investigation.The device was returned in a used condition.The visual inspection of the returned device showed no apparent damage to either the introducer sheath or the dilator.The hub of the sheath was not returned for examination.With the hub missing, it cannot be confirmed if the flare did not adequately fit the hub.The flare of the sheath, although narrow, was measured to be within specification.Due to compression of the flare within the hub, deformation of the sheath flare is unable to be confirmed as a damaged hub or manufacturing nonconformance.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device manufacturing record was reviewed with no notable gaps in production or processing.A review of the device history record showed one nonconformance related to this event, however these nonconforming devices were detected in quality control and there is no evidence of additional nonconforming product in house or in the field.It should be noted there were no other reported complaints for this lot number.The instructions for use (ifu) instructs the user to inspect the product upon removal from the package to ensure no damage has occurred.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.With the sheath hub missing, it cannot be confirmed whether tortuous patient anatomy, product use error or issues with manufacturing contributed to the failure mode of the device.Appropriate measures have been taken to address this failure mode.The appropriate personnel were notified.Per the quality engineering risk assessment no further action is required.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction - this mdr is being submitted to indicate the event is not reportable.Upon further review, it was determined that this event is not reportable per 21cfr part 803.50 as it does not meet the criteria for a death, serious injury or reportable product malfunction.A review of reporting software revealed there are no previous incidents of hub separation of the rssw sheath that lead to a death or serious injury.Additionally, review of risk documentation indicated that this malfunction is not likely to cause serious injury if it were to reoccur.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

• Brand Name: WITTICH NITINOL STONE BASKET
• Common Device Name: LQR DISLODGER, STONE BILIARY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7660443
• Report Number: 1820334-2018-01903
• Device Sequence Number: 16187031
• Product Code: LQR
• UDI-Device Identifier: 00827002058774
• UDI-Public: (01)00827002058774(17)201110(10)8366076
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K902944
• 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): 08/27/2020

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: 11/10/2020
• Device Model Number: G05877
• Device Catalogue Number: WNSB-12-24
• Device Lot Number: 8366076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 08/04/2020
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 10/04/2018; 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1