MAUDE Adverse Event Report: COOK INC CHECK-FLO ADAPTER; HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is currently under investigation.
Event or Problem Description
A patient of unknown gender and age was undergoing a ureteroscopy with laser lithotripsy procedure.The device was being placed on the flexible scope as irrigant squirted out in the physician's face.A second device was opened and the very same difficulty occurred.A third one was opened and used to completed the intended procedure.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 review of the complaint history, device history record, trends, and specifications 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.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.A review of device master record did not observe any non-conformances that may have contributed to this incident.Based on the information provided, and the results of the investigation, a definitive root cause could not be determined.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: CHECK-FLO ADAPTER
• Common Device Name: HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6000054
• Report Number: 1820334-2016-01095
• Device Sequence Number: 16342295
• Product Code: HET
• UDI-Device Identifier: 00827002154766
• UDI-Public: (01)00827002154766(17)190715(10)7124045
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K903124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 050885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1