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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 Description

It was reported in a literature article published in the international journal of pediatric otorhinolaryngolgy that a salivary stone extractor basket was unable to be opened and consequently had to be pulled with force from the patient during a right submandibular sialoendoscopy procedure.The article states the following information concerning the adverse event: "a computed tomography scan showed a 4.6 mm radio-opaque stone in the deep right submandibular gland duct with mild intraglandular ductal dilation proximal to the stone.The patient was then taken to the operating room for right submandibular sialoendoscopy and retrieval of the sialolith under general anesthesia.The stone was identified at the first hilum.It was adherent to the duct wall but was easily mobilized with irrigation and the use of a guidewire.The wire basket was introduced through the working channel of the endoscope and the stone was grasped without difficulty.The stone was then retracted distally toward the papilla until we encountered a narrowing deep in the duct that prevented us from pulling more distally.In the process, the wire basket kinked within the sialoendoscope's working channel and we couldn't release the stone from the basket nor remove the scope from the duct.After several minutes of attempts at removal, it was clear there had been catastrophic device failure since the basket would not open, therefore, neither the scope nor wire basket could be removed.The patient had previously been consented for possible gland removal, so at this point; we felt that our only option was brute force to remove the hardware.Significant pressure was applied to remove the scope/wire/stone complex, which was successful.In the process, the submandibular duct was avulsed.We were unable to recannulate the proximal end of the submandibular duct to attempt a sialodochoplasty, so the gland was excised transcervically." the article later states that this case had "favorable prognostic factors" for removing the stone using the sialoendoscopic technique as the maximum diameter of the oval-shaped stone was under 5 mm.The patient was reported to have no significant duct stenosis or stricture.The major "negative prognostic factor" was the stone's location deep into the patient's duct.Ultimately, the patient was reported to have had no complications as a result of the modified procedure.Literature citation: aljasser, a.And grischkan, j.M.(2016).Device failure in sialoendoscopy: intraoperative practical decision-making.International journal of pediatric otorhinolaryngology, 90, 193-195.Doi: 10.1016/j.Ijporl.2016.09.020.

Event Description

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

Manufacturer Narrative

Investigation - evaluation: from the review of a case study that was published 17sep2016, cook discovered an incident on 22feb20 involving a salivary stone extractor basket sseb-1.7-115-8 from an unknown lot that was used at the nationwide children's hospital.The device reportedly would not open after capturing a stone during a submandibular sialoendoscopy procedure.Further information clarified that the stone was captured by the basket, but a narrowing in the duct prevented the stone from being pulled distally.The basket wire then kinked within the sailoendoscope¿s working channel and the stone could not be released from the basket; consequently, the scope could not be removed from the duct.Brute force was then used to remove the hardware, which was successful.In the process, the submandibular duct was avulsed.The gland was then excised transcervically.This was done without complication and the patient recovered uneventfully without sequelae.A review of the instructions for use (ifu), manufacturing instructions (mi) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 device history record (dhr) could not be completed due to lack of lot information from the user facility.Because there are no known related non-conformances, adequate inspection activities have been established, and no other known lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Additionally, there is no indication that the product was not manufactured to specification.Cook also reviewed product labeling.The product ifu, provides the following information: ¿precautions ¿ 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.¿ 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, no product returned, and the results of the investigation, a definitive root cause was not able to be established.The information in the publication stated the size of the stone being removed was 4.6 cm and a size 1.3mm sialoendoscope was used.There was a narrowing of the duct that prevented the stone from being pulled out distally, resulting in the kinking of the basket wire.It appears there was possibly an issue with the anatomy of the patient that prevented the stone from being removed that resulted in the device becoming damaged.Without the device available for investigation, this is unable to be confirmed.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.

• 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: 9781759
• MDR Text Key: 192762728
• Report Number: 1820334-2020-00536
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K120468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SSEB-1.7-115-8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MARCHAL SIALOENDOSCOPE, KARL STORZ
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 64