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 Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for 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 transurethral resection (tur) procedure, the patient¿s urethra was injured when the ceramic insulation at the distal end of the resection sheath fractured inside the urethra.The procedure was prolonged by one hour to retrieve the fragments and a suprapubical catheter was placed.Furthermore, a follow-up tur procedure was scheduled.

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 resection sheath broke apart.Two of the fragments were returned as well.They show traces of thermal and mechanical damage.One of the fragments shows severe traces of mechanical force.Furthermore, there are traces of an electric arc on the inner surface of the ceramic insulation.Thus, the cause of this damage and the breakage of the ceramic insulation is most likely mechanical overload by the application of excessive force like impact, fall, shock or similar stress.Therefore, this event/incident was attributed to use error.Furthermore, 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 from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.In addition, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• 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
• MDR Report Key: 7559659
• MDR Text Key: 109748089
• Report Number: 9610773-2018-00050
• 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
• Report Date: 07/09/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 17YW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention