MAUDE Adverse Event Report: OSTA NON-CF RESECTOSCOPE STANDARD SHEATH, 28FR

Model Number ESRS-28

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation as two separate pieces.The evaluation confirmed the reported device damage.The shaft was found completely detached from the meatus washer.A visual inspection of the device found small peelings on the coating of the tip, missing red aligning dot, and light scratches.The device was tested with a test working element (eiwe) and passed through the channel with no problems.Based on the investigation findings, the cause of the reported event is likely attributed to user handling / excessive torque on the device during use.The instruction manual for use states, ¿warning: 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 crack, loosen, break, or otherwise damage the sheath¿s insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.If resistance is encountered during assembly or disassembly, stop and align working element and sheath parallel to one another before proceeding.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.Examine this device prior to use.¿.

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the tip of the obturator detached and fell inside the patient.The device fragment was retrieved with a non-olympus ((b)(6)) clamp.The procedure was completed using a different device.No patient injury reported.

• Brand Name: NON-CF RESECTOSCOPE STANDARD SHEATH, 28FR
• Type of Device: NON-CF RESECTOSCOPE STANDARD SHEATH, 28FR
• 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: 6455296
• MDR Text Key: 71582930
• Report Number: 2951238-2017-00216
• Device Sequence Number: 1
• Product Code: HIH
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESRS-28
• Device Catalogue Number: ESRS-28
• Device Lot Number: HW
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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