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); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience 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 in saline (turis) procedure, the ceramic insulation at the distal end of the inner sheath broke off and fell inside the patient's bladder.However, the fragment was reportedly retrieved.No further information was provided but the intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Additional information: lot #; device manufacture date.Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on (b)(6) 2017).The investigation confirmed that the ceramic insulation at the distal end of the inner sheath is damaged.Three fragments are broken off.The remaining portion of the ceramic insulation is cracked and scratched on its inner surface.Furthermore, the sheath tube is dented.The cause of this damage and the breakage of the ceramic insulation is mechanical overload by the application of excessive force like impact, fall, shock or similar stress.Therefore this event/incident was attributed to use error.The case will be closed from olympus side with no further actions.However, the 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: 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
• MDR Report Key: 7103964
• MDR Text Key: 95757609
• Report Number: 9610773-2017-00133
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• PMA/PMN Number: PK931995
• 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: 01/26/2018

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
• Device Catalogue Number: A22040A
• Device Lot Number: 156W
• Other Device ID Number: 04042761029339
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1