MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 12, LONG, STERILE, SINGLE USE, 12 PCS; HF-RESECTION ELECTRODES

Model Number	WA22037C
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical devices have not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the loop wires at the distal end of three hf resection electrodes broke.It is unknown when exactly this damage occurred and whether a fragment fell inside the patient.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Additional information: describe event or problem; device evaluation: the suspect medical device was returned to olympus for evaluation/investigation.The investigation confirmed that the loop wires at the distal end of three hf resection electrodes broke off.Furthermore, one of the loop wires showed discolorations (temper color), another loop wire showed material deposits.The cause of this damage and the breakage of the loop wires is most likely a contact with a conducting object and resulting short circuits.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of the hf resection electrodes without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the loop wires at the distal end of three hf resection electrodes broke and fell inside the patient.However, no fragment remained inside the patient since they were reportedly retrieved.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Additional information: describe event or problem; device evaluation: the suspect medical device was returned to olympus for evaluation/investigation.The investigation confirmed that the loop wires at the distal end of three hf resection electrodes broke off.Furthermore, one of the loop wires showed discolorations (temper color), another loop wire showed material deposits.The cause of this damage and the breakage of the loop wires is most likely a contact with a conducting object and resulting short circuits.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of the hf resection electrodes without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the loop wires at the distal end of three hf resection electrodes broke and fell inside the patient.However, no fragment remained inside the patient since they were reportedly retrieved.No further information was provided but there was no report about an adverse event or patient injury.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 12, LONG, STERILE, SINGLE USE, 12 PCS
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7604340
• Report Number: 9610773-2018-00057
• Device Sequence Number: 1623567
• Product Code: GCP
• UDI-Device Identifier: 14042761051566
• UDI-Public: 14042761051566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: WA22037C
• Device Catalogue Number: WA22037C
• Device Lot Number: P16Y0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1