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

Catalog Number A22014A

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

The resection sheath was not yet 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 an unspecified transurethral resection of the prostate (turp) procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient.No fragment/part remained inside the patient as the ceramic insulation was reportedly retrieved by unknown approach.However, the patient's urethra was injured during this retrieval.No further information was provided but the intended procedure was successfully completed with the same set of equipment and there was no report about an adverse event or serious 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 had broken off completely.However, the fragment was missing since it was not returned.Furthermore, the sheath tube is slightly deformed and shows a corroded scratch.Several parts of the resection sheath are clearly worn.Causal for this damage and the breakage of the ceramic insulation is thermal and 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 as a manufacturing and quality control review was performed for the affected lot number of the inner sheath without showing any abnormalities.As clearly stated in the instructions, the product has to be visually inspected and tested before use.It has to be ensured that it has no corrosion, dents or scratches.In particular the ceramic insulation has to be visually inspected before each use, and the instrument must not be used in case of damage (e.G.Cracks, fractures).In addition, it is pointed out as a warning note that impact, fall, shock or similar stress can damage the ceramic insulation and that the instrument must not be used if damaged as otherwise there is a risk of injury to the patient and/or user.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 he reportedly used the suspect medical device despite clearly visible corrosion and wear.Furthermore, the damage of the sheath tube and the breakage of the ceramic insulation were caused by thermal and mechanical overload.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 retrained to correctly use the olympus medical devices.

• Brand Name: RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION
• 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: 5194221
• MDR Text Key: 30498099
• Report Number: 9610773-2015-00053
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

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 Catalogue Number: A22014A
• Device Lot Number: 144W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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