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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Human Factors Issue (2948); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the physician was performing a sialoendoscopy procedure on a patient by using the ncircle salivary stone extractor basket (sseb).The physician attempted to retrieve 1 cm stone from wharton¿s duct.After several attempts, the physician observed that the basket became mangled and no longer could hold its original shape.The procedure was completed by opening a new basket.The customer further stated that they were trying to remove a large stone and there is a possibility that while retrieving the stone the operator may have applied excessive strength on the basket which may have caused this issue.No unintended section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation summary: a review of the functional test, complaint history, device history record, quality control and a visual inspection of the returned device were conducted during the investigation.One device was returned for investigation.The returned device was found to be damaged.The device was returned with the udh handle partially open and the basket formation partially open; the basket formation extends the end of the basket sheath 5 mm.There are multiple kinks throughout the basket sheath.A functional test was performed and the udh handle actuates the basket formation to the open and closed positions.A visual examination noted the basket formation appears flat; the basket wires knot has pulled apart.The collet knob is tight and secure.The mlla (male luer lock adaptor) is finger tight.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.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.The most likely cause for the observed damage was "operative vigor" during use of the device on a massive stone.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6728479
• MDR Text Key: 80565912
• Report Number: 1820334-2017-01806
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00827002237971
• UDI-Public: (01)00827002237971(17)200125(10)7622620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SSEB-1.5-115-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1