MAUDE Adverse Event Report: GYRUS ACMI, INC. ROTATING CF RESECTOSCOPE INNER SHEATH

Model Number ERIS-CF27

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Olympus received a voluntary medwatch report # (b)(4) which stated, "the doctor notified the staff in the room that the resectoscope sheath was broken at the tip while in use.It was inspected prior to start and was intact.All feasible pieces were removed." olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the reported phenomenon occurred during a transurethral resection of the prostate (turp) procedure.The patient's bladder was flushed out and the patient was informed not to be alarmed if small piece of plastic will be in his urine.The same device was used to successfully complete the procedure.No other equipment was replaced during the case.There was no patient injury reported.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause ot the reported event could not be conclusively determined.If additional information is received at a later time this report will be supplemented.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4900316
• MDR Text Key: 15566618
• Report Number: 2951238-2015-00301
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF27
• Device Catalogue Number: ERIS-CF27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1