MAUDE Adverse Event Report: OSTA ELITE 2 SYSTEM ROTATING CF RESECTOSCOPE OUTER SHEATH, 25FR

Model Number E2ROS-CF25

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

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 device was returned to olympus for evaluation.A visual inspection was performed on the returned condition of the device and found the outer sheath assembly was broken and missing the isolation beak.The broken tip was not returned.The broken portion was noted to have sharp at the edges at the tip.Based on the investigation findings, this type of damage is consistent with impact damage or excessive force applied during use.The instruction manual warns users always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may damage the sheaths distal tip.

Event Description

Olympus was informed that during an unspecified procedure, the teflon portion of the outer sheath broke off and resulted in a patient injury.It is unknown if the intended procedure was completed.No further information was provided.

Manufacturer Narrative

A review of the device history records (dhr) was conducted for the reported lot number.The device was manufactured in june 2003 and showed no issues or non-conformities during the production of the device during that month.

• Brand Name: ELITE 2 SYSTEM ROTATING CF RESECTOSCOPE OUTER SHEATH, 25FR
• Type of Device: RESECTOSCOPE OUTER SHEATH
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6097867
• MDR Text Key: 59717630
• Report Number: 2951238-2016-00856
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2ROS-CF25
• Device Catalogue Number: E2ROS-CF25
• Device Lot Number: FG
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention