MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING INSERT, ALBARRAN, TWO WAY; WORKING INSERTS WITH ALBARAN LEVER

Model Number A20972A

Device Problems Mechanical Problem (1384); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

The working insert 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 reprocessing after a therapeutic transurethral resection of the bladder tumor (turbt) procedure, it was noticed that the albarran lever at the distal end of the working insert could not be raised smoothly and that its fixing pin was missing.It is unknown when the fixing pin fell off.However, it was suspected that it would have been flushed out from the patient with irrigation fluid if it had detached during the turbt procedure.No further information was provided but the turbt procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.

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 2016-04-22).The evaluation/investigation confirmed that the albarran lever at the distal end of the working insert cannot not be raised smoothly and that its fixing pin is missing.Furthermore, the albarran lever is deformed and one of the instrument stopcocks has broken off and is missing.The cause of this damage is mechanical overload by the application of excessive force.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: WORKING INSERT, ALBARRAN, TWO WAY
• Type of Device: WORKING INSERTS WITH ALBARAN LEVER
• 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: 5596963
• MDR Text Key: 44212433
• Report Number: 9610773-2016-00020
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20972A
• Device Catalogue Number: A20972A
• Device Lot Number: 46W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2004
• 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