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U.S. Department of Health and Human Services

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

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COOK INC SALIVARY STONE EXTRACTOR BASKET SSEB GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
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.

 
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Brand NameSALIVARY STONE EXTRACTOR BASKET SSEB
Type of DeviceGCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9781759
MDR Text Key192762728
Report Number1820334-2020-00536
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
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 Received03/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberSSEB-1.7-115-8
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/03/2020 Patient Sequence Number: 1
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