MAUDE Adverse Event Report: OLYMPUS OES PRO ROTATABLE RESECTOSCOPE

Model Number A22040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 03/27/2014

Event Type  No Answer Provided  

Event Description

Pt underwent endoscopic treatment of prostatic bladder, status post transurethral resection.Surgeon experienced scope failure as the tip portion of the scope broke off and fell into bladder and was unable to retrieve in the course of attending to the pt's hemorrhaging and condition.Piece left in until pt more stable and pt taken to recovery room.In recovery room, pt became unstable and returned to surgery where surgeon performed open cystotomy for clot evacuation, foreign body removal and over-sewing of intra prostatic bleeding.Dates of use: approx 4 years.Diagnosis or reason for use: endoscopy cystoscopy.

• Brand Name: OES PRO ROTATABLE RESECTOSCOPE
• Type of Device: OES PRO
• Manufacturer (Section D): OLYMPUS; central valley PA 18034
• MDR Report Key: 3736548
• MDR Text Key: 4310317
• Report Number: MW5035536
• Device Sequence Number: 1
• Product Code: FJL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2014

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: A22040A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR