MAUDE Adverse Event Report: COOK INC STONEBREAKER SINGLE USE PROBE

Catalog Number	SBP-010605
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name/ product code: lithotriptor, electro-hydraulic/ ffl.Pma/510(k) #: k062475.(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 when gathering products for a recall response, a hair was observed in the sterile package of this stonebreaker single use probe.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A review of complaint history, the device history record, quality control data and specifications was also performed.One unopened package labeled rpn (b)(4), label lot number 7030045 was received.Visual examination of the sealed package confirmed a dark colored hair loose inside the sealed package.Review of the device history record found no non-conformances associated with the reported failure mode.A review of complaint history revealed there are no other complaints associated with the complaint product lot number 7030045.A document review was carried out and it was identified that the product line was inspected for foreign matter after being packaged.There were no additional complaints or non-conformances identified on the same lot.The cause of this complaint is manufacturing related.Measures have been initiated to address this failure.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: STONEBREAKER SINGLE USE PROBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7377182
• Report Number: 1820334-2018-00812
• Device Sequence Number: 1030980
• Product Code: FFK
• UDI-Device Identifier: 00827002526051
• UDI-Public: (01)00827002526051(17)190608(10)7030045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: SBP-010605
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1