MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY- AMERICA, INC. RESECTOSCOPE SHEATH

Model Number 27040 BO

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

During the procedure the device broke.The foreign body was removed from the patient and surgery was completed without incident.

• Brand Name: RESECTOSCOPE SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY- AMERICA, INC.; 15 wells street; southbridge MA 01550
• MDR Report Key: 5387515
• MDR Text Key: 36733393
• Report Number: 5387515
• Device Sequence Number: 1
• Product Code: OCX
• 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: Other
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Model Number: 27040 BO
• Device Lot Number: 0123 LOT 1A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR