MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR; HF RESECTION ELECTRODE LOOP

Model Number WA22302D

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation at this time.The exact cause of the event could not be confirmed at this time.However, based on similar reported events the reported event can occur from mechanical overload by the application of excessive force and improper handling/off-label use, when the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated and or with higher output settings on the electrosurgical generator.If addition additionally, the oem performed a dhr review for the concerned lot number without showing any non-conformities or deviations during the manufacturing process.

Event Description

Olympus was informed that during the middle of a transurethral resection of a bladder tumor procedure, the loop of the device broke off and fell inside the patient¿s bladder.The location of the broken loop was unknown as the broken loop could not be located inside the patient and/or if it came out during irrigation.The intended procedure was completed using a different device and there was no patient injury reported.In addition, there was no sparking observed; no patient bleeding; no issues withdrawing the device.The procedure was delayed (not specified) as there was a lot of time spent looking for the broken loop.The device was inspected prior to use with no anomalies noted.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Type of Device: HF RESECTION ELECTRODE LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7737853
• MDR Text Key: 115795588
• Report Number: 2951238-2018-00446
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000022035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1