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 Codes	Device Inoperable (1663); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 user facility reported upon opening, the salivary stone extractor basket would not grab and was not functioning properly.No adverse effects or consequences were reported to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the salivary stone extractor basket sseb was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of the complaint history, the device history record, documentation, and quality control data was conducted.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and observed that there were no non-conformances identified during the manufacturing process that would cause or contribute to the reported issue.A review of complaint history revealed there have been no other complaints associated with the complaint device lot number 7226225.Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined.Measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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: 7020863
• Report Number: 1820334-2017-03920
• Device Sequence Number: 1004900
• Product Code: GCJ
• UDI-Device Identifier: 00827002237988
• UDI-Public: (01)00827002237988(17)190921(10)7292233
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1