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

Model Number A22041A

Device Problem Break (1069)

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

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.However, the exact cause of the user's experience and the reported phenomenon could not be determined yet since the evaluation/investigation is still ongoing.As soon as the investigation results and final evaluation are available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic bladder procedure, the ceramic insulation at the distal end of the resection sheath broke off.It was reported that the resection sheath had been inspected before the procedure and that no abnormalities or irregularities were detected at that time.No further information was provided but there was no report about an adverse event or patient injury.

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 is broken off completely.The cause of this damage and the breakage of the ceramic insulation is thermal mechanical stress in combination with wear and tear.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.It is clearly stated as a warning note in the instructions that impact, fall, shock or similar stress can damage the ceramic insulation at the sheath's distal end and that the instrument must not be used if damaged since otherwise this can cause injuries to the patient and/or user.The user apparently did not follow these instructions since the damage and breakage of the ceramic insulation were caused by thermal mechanical stress.Therefore, this event/incident was attributed to use error and 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: 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
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6847595
• MDR Text Key: 86454317
• Report Number: 9610773-2017-00105
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

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: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 103W
• Other Device ID Number: 04042761020961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1