MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", 24 FR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22703S

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.As a preventive measure, the device instructions for use warns against bending the distal tip.The instructions for use also cautions, ¿if signs of wear become visible during the procedure, replace the product.¿ the instructions for use also have pre-procedure directions for inspecting both the device and its packaging for damage and deformation.

Event Description

Olympus was informed via medwatch report (b)(4) that during a cystoscopy with transurethral resection of prostate, the loop of the device broke in the middle and a fragment fell into the bladder.The fragment was washed out of the patient by flushing the bladder.There was no reported patient injury.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", 24 FR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• 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: 8201480
• MDR Text Key: 131916705
• Report Number: 2951238-2018-00817
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085332
• UDI-Public: 14042761085332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22703S
• Device Lot Number: 1000022942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 98