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

Lot Number 121W

Device Problems Break (1069); Component Falling (1105); Corroded (1131); Material Fragmentation (1261); Mechanical Problem (1384); Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the ceramic insulation of the suspect medical device broke and a fragment/part of approx.0,5 cm in size fell inside the patient's bladder.However, no fragment/part remained inside the patient as it was reportedly retrieved by unknown approach.The intended procedure was subsequently completed by using a similar device and there was no report about an adverse event or patient injury.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 damage.Furthermore, the breakage of the ceramic insulation was caused by mechanical overload/the application of excessive force by impact, fall, shock or similar stress.Therefore, this incident was attributed to abnormal use/off-label use in combination with exceeded service life/shelf-life and the case will be closed from olympus side with no further actions.However, the 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.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.Evaluation confirmed the reported phenomenon of a damaged ceramic insulation at the distal end of the resection sheath.A fragment/part of approx.1 cm in size is broken out.However, no parts are actually missing.The shape of the fracture surface as well as the considerably bent/deformed sheath tube indicates that the breakage was caused by mechanical overload/the application of excessive force like impact, fall, shock or similar stress.Furthermore the resection sheath was found with partially peeled off laser marking and slight corrosion in the area of the yellow gasket.There are clearly visible signs of abrasion at the sheath tube and the ceramic insulation.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 he 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 damage.Furthermore, the breakage of the ceramic insulation was caused by mechanical overload/the application of excessive force by impact, fall, shock or similar stress.Therefore, this incident was attributed to abnormal use/off-label use in combination with exceeded service life/shelf-life and the case will be closed from olympus side with no further actions.However, the 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.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTION SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; hamburg 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg ; GM
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; GM ; 0669662955
• MDR Report Key: 3983364
• MDR Text Key: 4890068
• Report Number: 9610773-2014-00026
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2014

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 Lot Number: 121W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2014
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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