MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING INSERT, ALBARRAN, TWO WAY

Model Number A20972A

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384); Device Or Device Fragments Location Unknown (2590)

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

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not 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 a therapeutic transurethral lithotripsy (tul) procedure, it was noticed that the albarran lever at the distal end of the working insert could not be raised 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 tul procedure.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 patient injury.

• Brand Name: WORKING INSERT, ALBARRAN, TWO WAY
• Type of Device: WORKING INSERT, ALBARRAN, TWO WAY
• 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 ; 4940669662
• MDR Report Key: 7059194
• MDR Text Key: 93704250
• Report Number: 9610773-2017-00127
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK790071
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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
• Other Device ID Number: 04042761020374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• 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: Reuse
• Patient Sequence Number: 1