MAUDE Adverse Event Report: ETHICON, INC GYNECARE VERSAPOINT; HYSTEROSCOPE

Device Problems Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

Small black rubber piece of the resectoscopic system got stuck in the resectoscope and had to be removed with a hemostat by the scrub tech.

• Brand Name: GYNECARE VERSAPOINT
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): ETHICON, INC; route 22 west,; po box 151; somerville, NJ 08876
• MDR Report Key: 4575090
• MDR Text Key: 17586114
• Report Number: 4575090
• Device Sequence Number: 1
• Product Code: HIH
• 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: 02/26/2015

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: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR