MAUDE Adverse Event Report: KARL STORZ ENDOVISION KARL STORZ; FLEXIBLE URETEROSCOPE

Model Number 11278AU1

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

Allegedly, during a kidney stone removal procedure, surgeon identified a small white piece of the ureteroscope in pt.He was able to remove it with a basket retriever.Procedure was completed with no pt impact.

Manufacturer Narrative

The instrument has not been returned for evaluation.The flexible ureteroscope originally shipped 02/28/2011 to a different facility and some how ended up at (b)(6) hospital.According to their risk manager, (b)(4) is the third party repair company they used for repair of this scope and other instruments.

• Brand Name: KARL STORZ
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; charlton MA
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill rd.; charlton MA 01507 525
• Manufacturer Contact: susie chen, complaint unit ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4635377
• MDR Text Key: 5617374
• Report Number: 1221826-2015-00021
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2015

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
• Device Operator: Health Professional
• Device Model Number: 11278AU1
• Device Catalogue Number: 11278AU1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR