MAUDE Adverse Event Report: COOK UROLOGICAL INC. OPEN-END URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 020015

Device Problem Tip breakage (1638)

Patient Problem Foreign body, removal of (2365)

Event Date 05/30/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

Event Description

A (b)(6) with microhaematuria and second degree strep uti underwent cystoscopy and left rpg on (b)(6) 2014.The scrub sister noticed foreign body in bladder when catheter was removed.Foreign body small yellow slither from inside ureteric catheter, was removed by surgeon.No adverse effects to the patient were reported due to this occurrence.Additional information provided (b)(4) 2014: after the foreign body was noticed on the screen it was removed with biopsy forceps through the cystoscope.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK UROLOGICAL INC.; spencer IN 47460
• Manufacturer Contact: rita harden, director ; po box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 3911598
• MDR Text Key: 19398887
• Report Number: 1820334-2014-00281
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2017
• Device Catalogue Number: 020015
• Device Lot Number: U2473456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR