MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 12, HD, AUTOCLAVABLE; RESECTOSCOPES

Model Number WA2T412A

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome 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 an unspecified procedure visibility issues occurred and due to the deposition of tissue on the device¿s distal end which lead to inadequate irrigation, the procedure could not be completed successfully.Five days later, a follow-up procedure was performed by a different surgeon using a similar device.This procedure could be completed but the surgery time was extended by approximately 25 minutes.

Manufacturer Narrative

Correction: device manufacturer date.Additional information: patient sex.Describe event or problem.Evaluation results: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus france (ofr).The evaluation at ofr confirmed that the light transmission did not meet the specifications and particles were found in the optical system as well as in the complete device.Furthermore the outer tube was found bent.The damage was caused by excessive force, which most likely led to the described visibility issues and deposition of tissue on the device¿s distal end.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the telescope without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

Event Description

Olympus was informed that during an urological procedure visibility issues occurred and due to the deposition of tissue on the device¿s distal end which lead to inadequate irrigation, the procedure could not be completed successfully.Five days later, a follow-up procedure was performed by a different surgeon using a similar device.This procedure could be completed but the surgery time was extended by approximately 25 minutes.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 12, HD, AUTOCLAVABLE
• Type of Device: RESECTOSCOPES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10288716
• MDR Text Key: 199556870
• Report Number: 9610773-2020-00158
• Device Sequence Number: 1
• Product Code: FBP
• UDI-Device Identifier: 04042761077507
• UDI-Public: 04042761077507
• Combination Product (y/n): N
• PMA/PMN Number: K151191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA2T412A
• Device Catalogue Number: WA2T412A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS OUTER SHEATH, 27 FR. (A22021A); OLYMPUS RESECTION SHEATH, 24 FR. (A22041A)
• Patient Outcome(s): Required Intervention