MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; HF CABLE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to the manufacturer for evaluation.The cause of the reported event could not be conclusively be determined.It was reported that a non-olympus generator in pure cut mode was being used at higher settings; first went from 220 watts, then to 180.Then the dr.Went down to a lower setting to complete the procedure.However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that during a transurethral resection procedure, an unspecified cable/cord was reportedly laying on the patient and caused the patient's skin to burn.The burn to the patient was observed after the procedure was completed.No additional details regarding the patient and cable were reported.

• Brand Name: HF-CABLE, MONOPOLAR
• Type of Device: HF CABLE
• 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: 9163508
• MDR Text Key: 161782971
• Report Number: 9610773-2019-00136
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention