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 Problem Break (1069)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2016-07-20).The evaluation/investigation confirmed that the ceramic insulation at the distal end of the inner sheath had broken off and cracked.However, no part was missing since all fragments were returned as well.The cause of this damage and the breakage of the ceramic insulation is fatigue due to long-term use (date of manufacture: 10/2003).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 case will be closed from olympus side with no further actions but the event/incident will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate in saline (turis-p) procedure, the ceramic insulation at the distal end of the inner sheath broke off and fell inside the patient.This reportedly occurred when the inner sheath, hf resection electrode and rigid cystoscope were repeatedly withdrawn from and reinserted into the outer sheath to remove burnt deposit on the hf resection electrode.No fragments remained inside the patient since they were retrieved with unspecified forceps.The intended procedure was successfully completed with another similar device and there was no report of any adverse event or patient injury.

• 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: 5828444
• MDR Text Key: 51385787
• Report Number: 9610773-2016-00035
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 07/28/2016

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 3XW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2003
• 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