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

Model Number	A20972A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device 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 or Problem Description
Olympus was informed that during an unspecified procedure at an unknown date, the albarran lever at the distal end of the working insert broke off.It is unknown whether a fragment fell inside the patient.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2018-05-21).The evaluation/investigation confirmed that a piece of the albarran lever at the distal end of the working insert had broken off.The cause of this damage is excessive heat resulting from laser irradiation.Therefore, this event/incident was attributed to use error.In addition, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the working insert without showing any abnormalities.The case will be closed from oste side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.In addition, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: WORKING INSERT, ALBARRAN, TWO WAY
• Common Device Name: WORKING INSERTS WITH ALBARAN LEVER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7559966
• Report Number: 9610773-2018-00051
• Device Sequence Number: 13736653
• Product Code: GCP
• UDI-Device Identifier: 04042761020374
• UDI-Public: 04042761020374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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
• Operator of Device: Health Professional
• Device Model Number: A20972A
• Device Catalogue Number: A20972A
• Device Lot Number: 142W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1