MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

Model Number WA22302D

Device Problems Break (1069); Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)

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

Event Date 08/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported to olympus that during a therapeutic procedure for transurethral resection of bladder tumor under general anesthesia, the surgeon used the electrical cutting loop to cut the tissue.The user found that the loop suddenly melted and broke with the missing length of 3mm.Upon careful examination of the broken end, spherical protrusions were formed at both ends of the loop.A cystoscope was used to repeatedly examine the bladder and a large amount of physiological saline was used for flushing.Due to bleeding in the surgical field a new electrical cutting loop was replaced for hemostasis and the procedure was completed with a similar device.The bleeding was expected and was not caused due to the device issue.No residual end of the loop was found inside the body.No damage was reported to the patient during procedure and no items fell inside the patient.No serious deterioration in the state of health of the patient.There was no injury reported and no relevant pre-existing conditions were noted.The device were inspected before the procedure.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
• Type of Device: HF-RESECTION ELECTRODE
• 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: 18341006
• MDR Text Key: 330659295
• Report Number: 9610773-2023-03650
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Lot Number: 1000108788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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