MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR

Model Number A22201C

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The three electrodes were not returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined, however, the loop wire breaking off the electrode and falling into a patient is a known issue and the oem has performed an investigation of the device and affected lot numbers.Based on the oem¿s investigation it has been determined that the loop wires of the affected electrodes became damaged during production due to some irregularities in the manufacturing equipment.As a result, a field safety corrective action has been initiated to prevent potential risk to patient health.If additional information becomes available or if the electrode is returned at a later date, this report will be supplemented accordingly.

Event Description

Olympus received a voluntary medwatch report (#mw5069524) that states the loop of an electrode broke and fell inside the patient during an unspecified procedure.The loop wire broke upon insertion in the uterus and it was the third time the loop broke off the electrode within two weeks.The loop was not recovered during the first procedure.The loops from the other two procedures, including this one, were recovered from the patients.Limited information was provided by the user facility.Multiple follow up attempts were made via telephone and in writing to gather more detailed information regarding the reported incident; however no additional information was obtained.3 of 3 electrodes.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Type of Device: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6652088
• MDR Text Key: 77922853
• Report Number: 2951238-2017-00415
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/19/2017

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: No Information
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: UNKNOWN
• Other Device ID Number: 14042761036648
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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