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	06/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name; het; odc, laparoscope, gynecologic (and accessories); endoscope channel accessory.The event is currently under investigation.
Event or Problem Description
The device is leaking instead of self-sealing.The facility is not for sure if it's leaking above or below the adapter.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
Blank fields on this form indicate the information is unknown, unavailable or unchanged.(b)(4).Investigation: a review of complaint history, device history record and specifications was conducted during the investigation.The product was not returned for the investigation.By report, when inserting an instrument, check-flo valve leaked.Procedure was completed with the device in place.Complaint is confirmed based upon customer testimony.Root cause could not be determined.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.Review of non conformances that may have contributed to this incident could not be performed as lot number was not provided.Devices from stock were leak tested, with one failure in a sample of 7 devices.We have notified the appropriate internal personnel of this event and will continue to monitor for similar complaints.Clinical input has been received.The event is no longer being considered reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or product malfunction as there is no indication of the malfunction leading to an adverse event.No harm to the patient has been reported.Some drainage is expected and accounted for during a urological procedure and constant irrigation and drainage is usually used to keep the field clear for the scope.A leak of this nature is of very little concern.
Event or Problem Description
The device is leaking instead of self-sealing.The facility is not for sure if it's leaking above or below the adapter.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.

• 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: 5744774
• Report Number: 1820334-2016-00557
• Device Sequence Number: 13518511
• Product Code: HET
• UDI-Device Identifier: 00827002154766
• UDI-Public: (01)00827002154766(17)190314(10)6810254
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 01/03/2017
• 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: Other