MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22002A

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2023

Event Type  Injury  

Event Description

A user facility reported to olympus that during a transurethral bladder tumor resection, when the electric scalpel was used with the telescope, 30°, 4 mm, the electrode contacted the tip of the rigid scope while arcing.The tip of the rigid scope (light source irradiation part) was then damaged.It was stated that the damage was visible visually.Part of the rigid endoscope "seemed" to have fallen out of the bladder, but it was initially unknown whether the fragment was recovered together with the perfusate using in the bladder.Since the operative field became pitch black, the rigid endoscope was replaced with an equivalent one and the procedure was completed.No delay occurred due to this.The physician later stated upon follow up that even if a piece had fallen off, it would flow out due to "reflux." it was determined that there was no residual device body, and no additional treatment was performed.Of note, there were no x-rays performed to confirm the location of the device.There was no reported health hazard that occurred patient and no change in the patient's condition postoperatively.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 19 years since the subject device was manufactured.Based on the results of the investigation, the reported event was attributed to user error.During the transurethral bladder tumor resection, the electrode touched the tip of the rigid scope and caused arcing.Furthermore, when using the endoscopic equipment in combination with hf electrodes, arcing may occur between the endoscopic equipment and the hf electrode.This may result in damage to the endoscopic equipment.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿warning: risk of damage to the product: when using the endoscopic equipment in combination with hf electrodes, there may be a sparkover between the endoscopic equipment and the hf electrode, which could result in damage to the endoscopic equipment.Make sure that the electrode is at least 10 mm away from all other endoscopic equipment.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 30°, 4 MM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17164446
• MDR Text Key: 317636861
• Report Number: 9610773-2023-01693
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020855
• UDI-Public: 04042761020855
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22002A
• Device Catalogue Number: A22002A
• Device Lot Number: 407457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2004
• 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
• Treatment: ESG-400 - SERIAL UNKNOWN; UNKNOWN LOOP ELECTRODE - LOT UNKNOWN
• Patient Outcome(s): Other