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

Catalog Number	SSEB-1.5-115-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported while preparing for a sialoendoscopy procedure the salivary stone extractor basket (sseb) package was opened.It was observed that one of the wires was broken; therefore, the device was not used on the patient.The procedure was completed by opening a new basket.There was no patient contact with the device.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a document based investigation has been performed which included review of drawings, manufacturing instructions, 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 and the basket formation in the open position.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length.A functional test noted the handle actuates the basket formation to the fully open position.A visual examination noted the basket formation is smashed.The wires look cross, all wires are present and secure.Several kinks noted in basket sheath from how the customer returned the device pressed between two trays.The customer has stated that one of the wires were broken, however during the investigation, all of the wires were found to be intact.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 there were two non-conformances noted.The non-conformance identified as ¿damaged¿ could possibly be related to the report failure.The other non-conformance is unrelated to the reported failure.A review of complaint history revealed one additional complaint for lot number 8003322.This other complaint was for the reported issue of foreign matter found during incoming inspection.The reported complaint of broken wire was not confirmed, but basket damage was confirmed based on the returned device.All devices are inspected for proper functioning and integrity before packaging.It is most likely the basket became damaged during shipping or handling of the device, but the exact root cause could not be determined.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: 6763893
• Report Number: 1820334-2017-02162
• Device Sequence Number: 16660315
• Product Code: GCJ
• UDI-Device Identifier: 00827002237971
• UDI-Public: (01)00827002237971(17)190426(10)6919998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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-1.5-115-10
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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: SIALENDOSCOPE.