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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a salivary duct procedure that the wires of a basket broke.A portion of one wire broke off in the patient's salivary duct and had to be retrieved.The patient did not experience any additional adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported during a salivary duct procedure that the wires of a basket broke.A portion of one wire broke off in the patient's salivary duct and had to be retrieved.The patient did not experience any additional adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, and quality control was conducted during the investigation.The device was not returned for further investigation.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of the non-conformance data revealed that the non-conformance listed on the device history record was not related to the reported failure.Based on the information provided and the results of our investigation, a definitive root cause could not be determined however, measures have been previously initiated to address this issue.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• 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: 5946676
• Report Number: 1820334-2016-00967
• Device Sequence Number: 16354354
• Product Code: GCJ
• UDI-Device Identifier: 00827002237971
• UDI-Public: (01)00827002237971(17)190323(10)6835513
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SSEB-1.5-115-10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 12/13/2016; 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention