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

Model Number	G23798
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): (b)(6).Occupation: (b)(6).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 that a salivary stone extractor basket was not opening correctly during a submandibular sialendoscopy procedure.The basket was passed through a scope to retrieve a submandibular stone.However, after 2-3 attempts to remove the stone, the physician noticed that the basket was not opening correctly.Repeated attempts to fix the basket were made but were not successful.A second device was used to complete the procedure with no adverse effects to the patient.
Additional Manufacturer Narrative
Investigation - evaluation: ipswich base hospital informed cook on 07dec2020 of an incident involving a salivary stone extractor basket (rpn: sseb sseb-1.7-115-8) from lot # 13268358.The basket of the device reportedly would not open correctly during a submandibular sialendoscopy procedure.Further communication with the user facility clarified that the basket was passed through a storz 1.6mm scope to retrieve a submandibular stone.Removal of the stone was attempted 2-3 times before the doctor realized that the basket was not opening correctly.Repeated attempts to fix the basket were unsuccessful.A second basket was opened and performed as expected.No adverse outcomes for the patient were reported.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 salivary stone extractor basket sseb with the handle/basket formation in the closed position was returned to cook for evaluation.A visual inspection noted that the mlla (male luer lock adapter) is loose, while the collet knob is tight and secure.The support sheath was bowed, the basket formation was flattened, and a kink in the basket sheath was noted near the distal tip.A functional test found that the handle actuates basket formation.Cook has concluded that the 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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (13268358) revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.As there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, 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, t _ tse_ rev4, provides the following information related to the reported 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 our investigation, a definitive root cause for this event could not be established.It is possible the distal end of the device was inadvertently damaged during use, causing the observed kinked sheath and incorrect basket shape.However, this cannot be confirmed without additional information.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 or Problem 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
• Common Device Name: GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11004258
• Report Number: 1820334-2020-02292
• Device Sequence Number: 17097075
• Product Code: GCJ
• UDI-Device Identifier: 00827002237988
• UDI-Public: (01)00827002237988(17)230625(10)13268358
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K120468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 06/25/2023
• Device Model Number: G23798
• Device Catalogue Number: SSEB-1.7-115-8
• Device Lot Number: 13268358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: KOLENDA ACCESS SHEATH, SDAS-6.0-18; STORZ 1.6MM SIALENDOSCOPE