MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF RESECTION ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22607D

Device Problem Failure to Cut (2587)

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

Event Date 09/24/2015

Event Type  malfunction  

Event Description

Just a few minutes into the case the surgeon noticed that the electrode was not cutting.Switched out electrode utilizing the same cord and completed the procedure without incident.Manufacturer response for hf-resection electrode, loop, 24 fr., olympus - hf-resection electrode (per site reporter): manufacturer provided rga# for product return evaluation.

• Brand Name: HF RESECTION ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 5187605
• MDR Text Key: 29813007
• Report Number: 5187605
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/01/2017
• Device Model Number: WA22607D
• Device Catalogue Number: WA22607D
• Device Lot Number: 989364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 99