MAUDE Adverse Event Report: GYRUS ACMI, INC ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR

Model Number ERVO-CF25

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the service center for investigation and is currently being retained by the hospital.As no lot number was provided, we are unable to determine the age of the device.

Event Description

The service center received a medwatch informed that during a therapeutic cysto transurethral resection of the prostate (turp) and bilateral rtg with stent procedure, the ceramic tip of the obturator, broke off.The device fragment piece did not fall into the patient and was observed on the procedure room floor.The broken instrument was removed from the tray and a new one was placed into the tray.The case was prolonged by 10 minutes while they looked for the broken piece.The procedure was completed was completed with a similar device.There was no patient injury reported.The obturator was inspected before use and no anomalies were noted.

• Brand Name: ROTATING CF RESECTOSCOPE VISUAL OBTURATOR, 25FR
• Type of Device: ROTATING CF RESECTOSCOPE VISUAL OBTURATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 9213443
• MDR Text Key: 168893028
• Report Number: 2951238-2019-01159
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2019

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: Health Professional
• Device Model Number: ERVO-CF25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1