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

Model Number WA00014A

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

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

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that an electrical failure occurred and no image during the hysteroscopic myomectomy and the same problem occurred after replacing all the combined devices causing a 30-minute delay in surgery and 30 minutes extended anesthesia time.There were no error messages.The procedure was completed using other urological products.The event did not affect the diagnostic or treatment outcome.There were no reports of patient harm.This event requires 12 reports.Related patient identifiers for the first combination of devices used are as follows: (b)(6) (wa00014a / hf-cable, bipolar) (b)(6) (wa00014a / hf-cable, bipolar) (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs) (b)(6) (a42021a / outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable) (b)(6) (wa22366a /working element, active, for resection in saline) (b)(6) (wb50402w / foot switch, double, for, esg-400) related patient identifiers for the second combination of devices used: (b)(6) (wb50402w / foot switch, double, for, esg-400) (b)(6) (wa22366a / working element, active, for resection in saline) (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs) (b)(6) (a42021a /outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable) (b)(6) (wa00014a / hf-cable, bipolar) (b)(6) (wa00014a /hf-cable, bipolar) this medwatch report is for patient identifier: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out.Additionally, to provide updates to fields (d4 -lot number, d9, h3, and h4).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported issue could not be determined as no fault or malfunction has been identified with the affected devices.It is possible that the phenomenon occurred due to a combination article used caused the reported error.Additionally, incorrect handling by the customer cannot be ruled out.However, a specific root cause of the phenomenon could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 17372299
• MDR Text Key: 319563275
• Report Number: 9610773-2023-01946
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 17YW-9012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• 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
• Treatment: FOOT SWITCH, DOUBLE, FOR, ESG-400.; HF-CABLE, BIPOLAR.; OUTER SHEATH, 8.5 MM / 26 FR.; RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR.; WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian