MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22041A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problems Dysuria (2684); Insufficient Information (4580)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic procedure, a fragment of the ceramic insulation at the distal end of the resection sheath broke off and fell into the patient's bladder.Since the broken fragment could not be retrieved, the procedure was changed to open surgery to remove the fragment.No further information was provided.

Manufacturer Narrative

Additional information: h6 - health effect - impact code.Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that part of the ceramic insulation at the distal end of the resection sheath is broken off and is missing.Furthermore, there are signs of corrosion at the seating of the yellow sealing.The type of damage found is typically caused by thermal and/or mechanical fatigue, possibly as a result of or in combination with improper reprocessing and/or excessive force.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert was pre-damaged at some point in the past, whether the damage was triggered during the reprocessing cycle preceding the incident, or during the procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed on olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

Manufacturer Narrative

The results of the device evaluation have already been submitted with medwatch 63424.

Event Description

Olympus was informed that during a therapeutic bladder biopsy with fluorescence procedure, a fragment of the ceramic insulation at the distal end of the resection sheath broke off and fell into the patient's bladder.Since the broken fragment could not be retrieved, the procedure was changed to open surgery to remove the fragment.The intended procedure was completed using a similar device but the patient sustained some damage to the urothelial urethra during removal of the broken fragment and suffered from slightly longer postoperative pain in the urethra during micturition.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12317526
• MDR Text Key: 266360046
• Report Number: 9610773-2021-00225
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

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: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 196W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/15/2021; 09/15/2021
• Supplement Dates FDA Received: 09/16/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention