MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS; ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number WA47706S

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2023

Event Type  Injury  

Event Description

The customer reported to olympus the hf-resection electrode "plasmaloop" was missing after being used in a patient during a hysteroscopy with fibroid resection.The loop was there when inserting device and when removing, the loop was missing.It was stated that the loop broke inside the patient and was not retrievable, and it potentially was retained by the patient.An x-ray after the procedure and a thorough examination of the uterus was done, but they were unable to visualize or locate the missing portion.It was stated that the procedure was unable to be completed.Additional follow up was requested.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17699301
• MDR Text Key: 322846052
• Report Number: 9610773-2023-02484
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA47706S
• Device Lot Number: W9200883 1000107584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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
• Patient Sex: Female