MAUDE Adverse Event Report: COOK INC DUCKBILL HYSTEROSCOPIC POLYP SNARE; FDI SNARE, FLEXIBLE

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that a patient underwent a procedure to remove polyps in the uterine cavity.The attending physician attempted to extract polyps by using a duckbill hysteroscopic polyp snare.The tip of the snare broke but did not separate.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, specification and quality control was conducted on the returned device during the investigation.A visual examination of the device noted a kink in the coil assembly between the snare and cannula near the tip of the sheath.Examinations of the snare noted one of the wires were loose.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 functional test was performed and the handle did actuate the snare without issue.Review of non-conformance data revealed that there were two non-conformances listed on the device history record, not related to complaint condition.Based on the provided information a definitive root cause cannot be established or reported at this time.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: DUCKBILL HYSTEROSCOPIC POLYP SNARE
• Common Device Name: FDI SNARE, FLEXIBLE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6343233
• Report Number: 1820334-2017-00309
• Device Sequence Number: 737311
• Product Code: FDI
• UDI-Device Identifier: 00827002545731
• UDI-Public: (01)00827002545731(17)180826(10)6155172
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-DHPS-555025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1