MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTOSCOPE

Model Number A22040A

Device Problem Material Fragmentation (1261)

Patient Problems Thrombus (2101); Device Embedded In Tissue or Plaque (3165)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Patient underwent cystoscopy for bladder clot evacuation and fulguration of bleeder at the upper bladder neck.A 24-french olympus resectoscope sheath with a 30 degree telescope in a visual obdurate was passed per the long urethra into the erosive fossa and bladder where careful panendoscopy was carried out.Multiple blood clots were noted in the prostate fossa and also filled up the large bladder lumen with clot tamponade.With the tip of the resectoscope sheaths in the bladder lumen, the working element was removed, and as soft tip 16 french suction tube was connected to the neptune suction machine, and intermittent suction was upright through the resectoscope sheath to disintegrate and evacuate the blood clots.Four months later, office cystoscopy was performed for examination and removal of suprapubic catheter.A foreign body was identified at that time and attempts to remove were unsuccessful.Surgical cystoscopy was required for dilatation of the bladder neck and removal of retained foreign body (rfb).The rfb was determined to be the ceramic tip of the inner sheath of the olympus resectoscope.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8503065
• MDR Text Key: 141574054
• Report Number: 8503065
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2019,04/04/2019

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: No Information
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 139W-0069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2019
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26280 DA
• Patient Weight: 121