MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. RESECTOSCOPE; ENDOSCOPE AND ACCESSORIES

Model Number 27040 XA/XC

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/12/2016

Event Type  malfunction  

Event Description

During surgery, sheathing tip broke off and was lodged into patient.Surgeon was able to remove broken tip from the patient.No patient harm.

• Brand Name: RESECTOSCOPE
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90247
• MDR Report Key: 6088825
• MDR Text Key: 59470746
• Report Number: 6088825
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• 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: 10/27/2016

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: Physician
• Device Model Number: 27040 XA/XC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2016
• Event Location: Other
• Date Report to Manufacturer: 10/27/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR