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 Type  malfunction  

Manufacturer Narrative

The device was returned to olympus in a biohazard condition and therefore no evaluation was performed.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The exact cause of the reported event could not be determined.However, based on similar reports, the most likely root cause could be attributed to user handling.The instruction manual for use states, "do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use." if additional information become available at a later time this report will be supplemented accordingly.

Event Description

Olympus was informed that during an unspecified procedure, the tip of the inner sheath broke off inside the patient.It was reported that there were no sharp edges noted as a result of the breakage.It is unknown if the device fragment was retrieved or if the intended procedure was completed.There was no patient injury reported.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ROTATING CF RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7042542
• MDR Text Key: 93341079
• Report Number: 2951238-2017-00732
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2017

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: ERIS-CF27
• Device Catalogue Number: ERIS-CF27
• Device Lot Number: GK
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/17/2017
• 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