MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22040A

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

Patient Problem Laceration(s) (1946)

Event Date 12/16/2020

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 a therapeutic bladder procedure to dislodge a clot, the ceramic insulation at the distal end of the inner sheath broke off and fell into the patient¿s bladder.Since the fracture site was very sharp, the distal end of the inner sheath lacerated the bladder.The injury was treated by cautery and the broken fragment was retrieved using forceps.The procedure was extended by approx.20 minutes as a result.However, the intended procedure was completed using the same set of equipment and the patient is doing fine now.Reportedly, the inner sheath had not been inspected before the procedure.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the ceramic insulation at the distal end of the inner sheath is broken off and is missing.The cause of this damage is most likely thermo-mechanical fatigue caused by wear and tear possibly in combination with excessive force.Thus, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert had already been pre-damaged or worn before the incident, whether the damage was triggered during the reprocessing cycle preceding the incident, or during the actual procedure.The sheath also has several dents and the laser marking is illegible, which is why the lot number of the item could not be identified and thus a dhr review could not be performed.Instead a manufacturing and quality control review was performed for the last 24 months of production.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• 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: 11064537
• MDR Text Key: 227215100
• Report Number: 9610773-2020-00298
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• 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
• Report Date: 02/17/2021

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention