MAUDE Adverse Event Report: OLYMPUS ENDOSCOPE RESECTOSCOPE SHEATH, F

Model Number A22040T

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2018

Event Type  malfunction  

Event Description

Approx 1 centimeter of the ceramic/plastic tip of the olympus endoscope resectoscope sheath, french broke off into the surgical site.The physician was able to grasp and removed it without injury to the pt.The mfr's device rep was on-site at the time of the event and was made aware of the incident.

• Brand Name: ENDOSCOPE RESECTOSCOPE SHEATH, F
• Type of Device: ENDOSCOPE RESECTOSCOPE SHEATH, F
• Manufacturer (Section D): OLYMPUS; southborough MA 01772
• MDR Report Key: 7299523
• MDR Text Key: 101149215
• Report Number: MW5075525
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040T
• Device Catalogue Number: A22040T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR