MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, 45 NEEDLE, 24-28 FR.

Model Number A22255C

Device Problem Break (1069)

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

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the service center for evaluation as the user facility discarded the device after the procedure; however, the staff was going see if the device could be retrieved.The cause of the reported event cannot be determined at this time.Based on similar device reports, the most probable cause of the reported broken hf electrode tip can be attributed to: physical damage, excessive output from the generator, and/or metal to metal contact with the hf electrode.The instruction manual warns users "warning! read all instruction manuals thoroughly.Before use, read this manual, the olympus endoscopy system guide, and the manuals for all other equipment which will be used during the procedure.An insufficient understanding of the dangers, warnings, cautions and information in these manuals can result in death, serious injury or equipment damage.When attaching the electrode, make sure not to push it too forcefully into the working element.Otherwise the electrode may be damaged." if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

The service center was informed that during an unspecified procedure, the doctor observed that the sterile disposable electrode needle broke off and fell into the patient¿s bladder.The doctor was able retrieve the metal device fragment.The intended procedure was completed.There was no patient injury reported.

Event Description

Service center was received additional information regarding the event.There were no reports of difficulties with inserting or withdrawing anytime during the procedure.The patient was transferred to the post-anesthesia recovery in good condition.The scope used during the procedure was wa22067a model and the serial number is unknown.

Manufacturer Narrative

A device history record (dhr) was performed and no non conformances related to the complaint were noted.

• Brand Name: HF-RESECTION ELECTRODE, 45 NEEDLE, 24-28 FR.
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8654958
• MDR Text Key: 146642597
• Report Number: 2951238-2019-00889
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036839
• UDI-Public: 14042761036839
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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
• Device Operator: Health Professional
• Device Model Number: A22255C
• Device Catalogue Number: A22255C
• Device Lot Number: 160204PO2L001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE MODEL WA22067A
• Patient Age: 73 YR
• Patient Weight: 95