MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ELECTRODES, PROBES

Model Number WA22507D

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress; however, should additional relevant information become available, a supplemental report will be submitted accordingly.Additional d1: hf-resection electrode, loop, 24 fr., 0.2 wire, large, 30°, sterile, single use, 12 pcs., for turis.

Event Description

The customer reported that during a transurethral resection of the prostate, intermittent insufficient conductivity error code, e006, occurred causing the procedure to halt intermittently.The procedure was completed with the hospital¿s own monopolar system.The device was returned for evaluation and the evaluation identified the following reportable malfunction: the loop and forks at the distal end of the electrode were deformed.No injury to the patient has been reported.Related patient identifier: (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information regarding the event.As part of the investigation, olympus followed up with the customer to obtain additional details regarding the event.The customer further reported that the olympus bipolar working element and electrode were used in the first part of the procedure.Saline was used for irrigation.No sparking occurred during the procedure.As a result of the error, the intended turp procedure was prolonged during the start of the operation for about 30 minutes because they needed time to change from olympus tur in saline (biopolar) to the valley lab monopolar system.The patient did required additional sedation or anesthesia.Additionally, the electrode was inspected prior to use with no abnormalities observed.The investigation is still in progress.However, if additional relevant information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 months since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the deformed loop could not be identified.However, it's likely the cause is related to improper use and excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ELECTRODES, PROBES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18016743
• MDR Text Key: 326730993
• Report Number: 9610773-2023-03090
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Model Number: WA22507D
• Device Lot Number: 1000118449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/27/2023; 04/12/2024
• Supplement Dates FDA Received: 12/07/2023; 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS: A22002A, TELESCOPE.; OLYMPUS: A22026A, OUTER SHEATH.; OLYMPUS: A22041T, RESECTION SHEATH.; OLYMPUS: WA00014A, LOT 203W0978, SALINE CABLE.; OLYMPUS: WA00014A, LOT 217W7290, SALINE CABLE.; OLYMPUS: WA00014A, LOT 217W7294, SALINE CABLE.; OLYMPUS: WA22366A, WORKING ELEMENT.; OLYMPUS: WB91051W S/N (B)(6), GENERATOR.