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

Model Number WA22302D

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Perforation (2001)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events.The exact cause of the reported event could not be conclusively determined at this time.However, based on the similar reported events, a broken loop can likely occur from mechanical overload by the application of excessive force and improper handling and or the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated.If the device is returned at a later date, this report will be supplemented accordingly.

Event Description

Olympus was informed that during an unspecified procedure, the bipolar electrode exploded inside the patient¿s bladder and caused three perforations.The patient underwent open surgery to repair the bladder.The intended procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to remove a statement below provided in a previous report as this information belongs to another report.¿however, based on the similar reported events, a broken loop can likely occur from mechanical overload by the application of excessive force and improper handling and or the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated.¿ this statement was entered in error and should be disregarded.

• Brand Name: HF-RESECTION ELECTRODE, LOOP,
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8253734
• MDR Text Key: 133259983
• Report Number: 2951238-2019-00369
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 02/06/2019
• 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 Outcome(s): Required Intervention