MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA URETEROSCOPE

Model Number 11278AU1

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/02/2014

Event Type  Injury  

Event Description

While using the scope, the surgeon noted a small foreign body in the kidney during a stoma removal procedure, he was unable to remove the object or definitively identify the object during the case.After the procedure, the physician requested another scope to compare them.At that point, it was identified that the scope used for the procedure was missing a small white piece from the tip of the scope.

• Brand Name: URETEROSCOPE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA; el segundo 90245
• MDR Report Key: 4085190
• MDR Text Key: 4857451
• Report Number: MW5038156
• Device Sequence Number: 1
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Weight: 93