MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)

Model Number WA22367A

Device Problems Electrical Shorting (2926); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Shaking/Tremors (2515)

Event Date 03/24/2021

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 transcervical resection (tcr) procedure, the patient started shaking and suffered an episode of bradycardia with a heart rate drop from 90 to 30.When the surgeon stopped activation, the patient heart rate slowly returned to normal.Upon reactivation, the patient leg started shaking again and the patient went into bradycardia again.The resectoscope set, hf cable, hf resection loop electrode, and hf generator were replaced but the same incident happened again.The intended procedure was completed and the patient was transferred to the high dependency ward for heart rate monitoring.No further information was provided but there were no reports of any device malfunctions.

Manufacturer Narrative

Additional information: b1 - report type, b2 - outcomes attributed to adverse event, d4 ¿ lot number, h4 ¿ device manufacturer date, h6 - device code.Device evaluation: the suspect medical device and the concomitant medical products were returned to the manufacturer for evaluation/investigation.Regarding the working element of this complaint and the second working element provided, as well as the two hf electrodes, the investigation did not reveal any anomalies, malfunctions or defects that may have caused the reported event/incident.However, the investigation of the two hf cables provided showed that the insulation at the right angle plug is missing and the socket is protruding.This probably caused a short circuit, which led or contributed to the reported event/incident.In addition, there are scratch marks visible and the overmold must have been cut off.These details indicate that the items were handled or reprocessed improperly by the customer.Thus, the reported event/incident was attributed to use error.A material or quality problem can be excluded for all articles involved since a manufacturing and quality control review was performed for the affected lot numbers of the working elements, hf electrodes, and hf cables without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
• Type of Device: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11593996
• MDR Text Key: 245939558
• Report Number: 9610773-2021-00109
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 118W-0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A).; OLYMPUS HF-CABLE, 4 M (WA00013A).; OLYMPUS UES-40 ELECTROSURGICAL UNIT.; UNSPECIFIED OLYMPUS LOOP ELECTRODE.; UNSPECIFIED OLYMPUS RESECTOSCOPE SET.
• Patient Outcome(s): Hospitalization