MAUDE Adverse Event Report: COOK, INC. ECHOTIP ULTRA; CATHETER

Catalog Number ECHO HD 22 EBUS P

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

During broncoscopy, the cook needle kit attachment used with the pentex bronchoscope did not function properly.The port did not release the biopsy needle after aspiration.The cook needle is unaccepatble to the surgeon.He required 3 needles to be used for the case.The connection, which is a leur lock connection, loosens repeatedly.The scope is frequently sent out for repair at a cost of approximately $2500 - $3000.Md requests equipment design review by physicians at pentex who are responsible for the design of the scope to develop it's own compatible needle biopsy kit.
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manufacturer response for pentex bronchosope and cook needle kit, pentex bronchoscope ebus (per site reporter).
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the manufacturer has promised to develop/design an appropriate needle biopsy kit that is completely compatible with the pentex bronscope but thus far that is not complete or approved.The cook needle kit is the only compatible needle device.

• Brand Name: ECHOTIP ULTRA
• Type of Device: CATHETER
• Manufacturer (Section D): COOK, INC.; 750 daniels way; p.o. box 489; bloomington IN 47402
• MDR Report Key: 4264334
• MDR Text Key: 5295214
• Report Number: 4264334
• Device Sequence Number: 1
• Product Code: FCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: ECHO HD 22 EBUS P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; PENTEX BRONCHOSCOPE.
• Patient Age: 59 YR
• Patient Weight: 108