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); Detachment Of Device Component (1104); Material Fragmentation (1261)

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

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus 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 transurethral resection of the prostate (turp) procedure, the ceramic insulation at the distal end of the inner sheath broke off and fell inside the patient's bladder upon insertion.However, no fragments remained inside the patient since the ceramic insulation was crushed into little pieces which were then flushed out.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.Furthermore, the inner sheath is in poor condition with peeling off laser marking, corrosion, contamination and residues due to improper reprocessing.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.In addition, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the inner 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 mechanical overload.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: 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
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 6787391
• MDR Text Key: 83114066
• Report Number: 9610773-2017-10005
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• 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: 157W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• 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