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

Catalog Number	J-DHPS-555025
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/02/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that during the hysteroscopy polyp removal procedure, the physician was not able to pull back the lasso/robe, because device resistant to pull back more.Therefore, a polyp was not burnt completely.It was further noted that one wire from the braid was noted to be broken.There was more pain to the patient reported due to the event.

• 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: 8138691
• Report Number: 1820334-2018-03652
• Device Sequence Number: 2266983
• Product Code: FDI
• UDI-Device Identifier: 00827002545731
• UDI-Public: (01)00827002545731(17)170601(10)5087988
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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 Expiration Date: 06/01/2017
• Device Catalogue Number: J-DHPS-555025
• Device Lot Number: 5087988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1