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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a ureteroscopy procedure the check-flo adapter leaked.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any 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 that during a ureteroscopy procedure,the check-flo adapter leaked.A section of the device did not remain inside the patient's body and the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, functional test, specification and visual inspection of the returned device was conducted during the investigation.Check-flo adapter was returned for investigation.Based on the functional evaluation of the returned products, the complaint is confirmed.There is no indication that a design 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 the nonconformance revealed (27) twenty-seven non-conformances for ¿failed test-leakage¿ which was related to this failure mode and the product was scrapped.A trackwise search revealed 1 additional reported complaint(s) associated to the same lot number.Based on the provided information, the root cause is manufacturing process related.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: 5818679
• Report Number: 1820334-2016-00692
• Device Sequence Number: 594004
• Product Code: HET
• UDI-Device Identifier: 00827002154766
• UDI-Public: (01)00827002154766(17)190211(10)6729091
• 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,Followup
• Report Date (Section B): 05/19/2017

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?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 10/24/2016; 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1