MAUDE Adverse Event Report: GYRUS ACMI / OLYMPUS SURGICAL TECHNOLOGIES AMERICA RESECTOSCOPE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Event Description

Ceramic end of urological instrument broke off on the tip of the instrument during surgery.This piece was found on the floor before the surgery ended and it matched the original instrument tip perfectly.Surgeon aware.Fda safety report id# (b)(4).

• Brand Name: RESECTOSCOPE
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI / OLYMPUS SURGICAL TECHNOLOGIES AMERICA
• MDR Report Key: 9075700
• MDR Text Key: 158974900
• Report Number: MW5089810
• Device Sequence Number: 1
• Product Code: FDC
• 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: 09/12/2019

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• 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: 61 YR
• Patient Weight: 112