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

Catalog Number A22040A

Device Problem Break (1069)

Patient Problems Complaint, Ill-Defined (2331); Foreign Body In Patient (2687)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Olympus was informed that after an unspecified transurethral resection of the prostate (turp) procedure, the operating surgeon noticed that the ceramic insulation at the distal end of the suspect medical device had broken off and was missing.However, it was suspected that this damage occurred during cleaning/reprocessing and not during the procedure.Subsequently, the patient felt unwell and was examined by ultrasound where a foreign object was found in the bladder.However, this was incorrectly identified as a bladder stone and no further actions were taken.The patient then went to a different hospital where the fragments/parts of the broken off ceramic insulation were discovered in and retrieved from the bladder during a conventional/open surgical procedure.The patient was subsequently hospitalized for recovery.

Manufacturer Narrative

The suspect medical device was not yet returned to the manufacturer 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.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore the manufacturer's evaluation/investigation was exclusively perfomed on the basis of the provided information.According to the available photo documentation, the ceramic insulation had completely broken off from the distal end of the inner sheath.Furthermore, there are heavy burn marks on the surface of the ceramic insulation.Causal for this kind of damage is thermal overload which, in combination with mechanical overload, led to the subsequent breakage of the ceramic insulation.Furthermore, the suspect medical device was reportedly inspected at the user facility by an olympus field service engineer.During this inspection, it was noticed that the inner sheath was repaired/serviced by an unauthorized service center.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 as otherwise this can cause injuries to the patient and/or user.Furthermore, it is pointed out that if the product is damaged or does not function properly, an olympus representative or an authorized service center has to be contacted.The user apparently did not follow these instructions as the damage and breakage of the ceramic insulation was caused by thermal and mechanical overload.Furthermore, the inner sheath was repaired/serviced by an unauthorized service center.Therefore this event/incident was attributed to abnormal use/off-label use 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 and the user will be informed about the investigation results and pro re nata trained again on the correct usage of the olympus medical devices.

Event Description

Olympus was informed that after an unspecified transurethral resection of the prostate (turp) procedure in (b)(6) 2014, the operating surgeon noticed that the ceramic insulation at the distal end of the suspect medical device had broken off and was missing.However, it was suspected that this damage occurred during cleaning/reprocessing and not during the procedure.Subsequently, the patient felt unwell and was examined by ultrasound where a foreign object was found in the bladder.However, this was incorrectly identified as a bladder stone and no further actions were taken.In (b)(6) 2015, the patient felt unwell again and went to a different hospital for examination where the fragments/parts of the broken off ceramic insulation were discovered in and retrieved from the bladder during a conventional/open surgical procedure.The patient was subsequently hospitalized for recovery and will be released soon.

• 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, 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 4066966
• MDR Report Key: 4814643
• MDR Text Key: 18785151
• Report Number: 9610773-2015-00021
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

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 Catalogue Number: A22040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: WORKING ELEMENT, PASSIVE, FOR TURIS ((B)(4))
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 70