MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. KARL STORZ; FLEXIBLE URETEROSCOPE

Model Number 11278AU1

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

Allegedly, during a kidney stone removal procedure, doctor noticed a small white foreign body in the kidney.He was unable to identify or remove foreign object during the case.Later, he identified that scope used for the procedure was missing a small inner white sleeve from distal tip.A week later, he scheduled an ureteroscopy to remove a stent and retrieved small white piece at that time.Procedure was completed with no injury to patient.

Manufacturer Narrative

The instrument has not been returned for evaluation.The flexible ureteroscope has a manufacturing date of july 2011.It was shipped to a different facility in (b)(4) 2012 and not (b)(6).Their risk manager confirmed that (b)(4) is the third party repair company they used for repair of this scope and other repairs.

• Brand Name: KARL STORZ
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; charlton MA
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill rd.; charlton MA 01507 525
• Manufacturer Contact: susie chen ; 2151 e. grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4269426
• MDR Text Key: 16862860
• Report Number: 1221826-2014-00050
• 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: 09/16/2014

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: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: 47 YR
• Patient Weight: 93