MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING; HF-RESECTION ELECTRODES

Model Number WA47786A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified procedure at an unknown date two years ago the loop wire at the distal end of the loop electrode broke off and fell into the patients body cavity.This was not noticed at the time of the procedure but only recently.An x-ray examination confirmed that the loop wire is still in the patient and a follow-up procedure is to be scheduled to remove the broken fragment.No further information was provided.

Event Description

Olympus was informed that during an unspecified procedure at an unknown time two years ago, the loop wire at the distal end of the loop electrode broke off and fell into the patient's body cavity.This was noted at the time of the procedure, but the fragment could not be recovered despite curettage.A transvaginal ultrasound examination was performed the following day, which revealed no free fluid in the douglas.The patient was informed about this and it was discussed that a follow-up examination could be performed in three months.If further discomfort occurred by then, surgical intervention could be considered, and during the same procedure, the wire could then be retrieved.No further information was provided.

Manufacturer Narrative

Additional information: b5 - describe event or problem.

Manufacturer Narrative

Additional information: b5 - describe event or problem; a3 - patient sex.Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer.However, with the limited event information provided, no photographic evidence of the failure mode and without the complaint device to evaluate, a definitive root cause for the reported failure could not be determined.Potential causes considered in the product risk analysis document are defective materials, a manufacturing issue (inadequate material strength), incorrect assembly of the electrode to the scope, misuse (e.G.Tip burial or activation in air pocket).However, based on the information available, the exact cause of the patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation result.

• Brand Name: VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): GYRUS MEDICAL LTD.; fortran road; st. mellons; cardiff
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15948284
• MDR Text Key: 305141852
• Report Number: 9610773-2022-00614
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761086257
• UDI-Public: 14042761086254
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA47786A
• Device Catalogue Number: WA47786A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 01/24/2023
• Supplement Dates FDA Received: 01/17/2023; 01/26/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female