MAUDE Adverse Event Report: COOK INC SALIVARY STONE EXTRACTOR BASKET SSEB; GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number G23798

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a salivary stone extractor basket was unable to open/close properly as the device's handle was broken.The surgeon was placing the device in the "working channel of scope" during a "sialendoscopy/sialolithiasis" procedure.It was discovered that the basket would not open as the physician was attempting to grasp a stone.The scope was removed "via the working channel" and a new device was used to successfully complete the procedure.The physician and resident were instructed on how to use the device and the device was tested before use.No adverse effects to the patient have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation vanderbilt university medical center informed cook on 04sep2020 of an incident involving a salivary stone extractor basket (rpn: sseb-1.7-115-8).The device reportedly would not open/close during a sialendoscopy/sialolithiasis procedure on (b)(6) 2020.Further communication with the user facility clarified that the device¿s handle was discovered broken after placing the basket in the working channel of the scope.The basket was tested prior to use.Another device was successfully used to complete the procedure with no reported harm to the patient.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One used salivary stone extractor basket was returned to cook for evaluation.Upon visual inspection, it was noted that the device was returned with the handle and basket formation both in the open position.When in the closed position, the basket formation/wires of the basket are slightly gapped.The basket wires were slightly deformed, with the appearance they may have been caught on something during use.A functional test of the device found that the device handle actuates the basket formation to the open and closed positions.Cook has concluded that this device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot (9639977) revealed no recorded non-conformances.A database search found one other event associated with the complaint device lot reported from the same customer for a similar issue in which no evidence of design/manufacturing issues were found.As there are no related non-conformances, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu provides the following information in relation to the failure mode: ¿precautions ¿ this product is intended for use by physicians trained and experienced in sialendoscopy.Standard sialendoscopic techniques should be employed.¿ assess calculi and other foreign bodies prior to instrument deployment to ensure that the object is no too large to be removed through the anatomy.(factors predicting successful stone retrieval with sialendoscopy-assisted basket retrieval include stone size (less than 3 or 4 mm for parotid and submandibular stones, respectively), shape (long and narrow or round), orientation (largest dimeter parallel to duct), distal location of the stone in the main salivary duct, and if calculus is free-gloating after ductal irrigation.Note that each patient's anatomy will vary) ¿ if resistance is encountered while attempting to remove calculi or other foreign bodies, release the object.Excessive force could damage the device.¿ if the basket does not readily release the captured object, further manipulation may be necessary.¿ during device withdrawal, take care to keep the shaft as straight as possible.Withdrawing the device at an excessive angle or curvature may damage the shaft.¿ based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause was unable to be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SALIVARY STONE EXTRACTOR BASKET SSEB
• Type of Device: GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10554447
• MDR Text Key: 207568145
• Report Number: 1820334-2020-01715
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00827002237988
• UDI-Public: (01)00827002237988(17)220403(10)9639977
• Combination Product (y/n): N
• PMA/PMN Number: K120468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: G23798
• Device Catalogue Number: SSEB-1.7-115-8
• Device Lot Number: 9639977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR