MAUDE Adverse Event Report: OSTA ROTATING CF RESECTOSCOPE INNER SHEATH

Model Number ERIS-CF27

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Perforation (2001)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined; however, the most likely root cause could be attributed to user handling.The instruction manual contains several warning statements in an effort to prevent damage to the ceramic beak of the device.¿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.¿ olympus made multiple follow ups by telephone and in writing in an attempt to obtain additional information regarding the reported event; however, no additional information was obtained.

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the tip of the resectoscope detached inside the patient's bladder.The surgeon attempted to retrieve the tip for 1.5 hours without success.The patient subsequently developed abdominal distention and was found to have a bladder perforation.The patient underwent an exploratory laparotomy and two additional surgeries to repair the bladder.The plastic tip was found stuck in the prostatic urethra.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ROTATING CF RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5885809
• MDR Text Key: 52415061
• Report Number: 2951238-2016-00689
• 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: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF27
• Device Catalogue Number: ERIS-CF27
• Device Lot Number: UNKNOWN
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 64