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

Catalog Number	SSEB-1.7-115-8
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that one of the salivary stone extractor basket wires was twisted.The basket was not fully deploying and the stone was not able to be captured in the basket during a sialoendoscopy.The physician was able to drag the basket along the ductal wall with the stone to remove the stone.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a document based investigation has been performed which included review of complaint history, the device history record, instructions for use, quality control data, and specifications.Visual inspection and functional testing of the returned device was also conducted.One device was returned for investigation.The device was returned with the handle in the closed position and the basket formation in the closed position.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3.7 cm in length.A visual examination noted the basket sheath and the support sheath are bowed starting at approximately 5 mm from the nose of the mlla.There were kinks in the basket sheath at 14 cm and 53.5 cm from the distal tip of the basket sheath.A functional test determined the handle actuates the basket formation to the open and closed position but the basket formation does not open fully.The clear basket sheathing has been scrunched up, which is preventing the basket formation from opening fully.The wires on the basket formation have the appearance of being hooked on something.Current controls are in place in manufacturing to assure device functionality prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history revealed this is the only complaint associated with lot number 7243858.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint device was found to have a basket that would not fully open due to sheath damage.The sheath was found to be kinked in multiple locations.The kinks prevented the basket subassembly from moving freely within the sheath when the handle was functioned.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use of the device.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.

• 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: 7515971
• Report Number: 1820334-2018-01475
• Device Sequence Number: 13859605
• Product Code: GCJ
• UDI-Device Identifier: 00827002237988
• UDI-Public: (01)00827002237988(17)190901(10)7243858
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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 Catalogue Number: SSEB-1.7-115-8
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1