MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, BIPOLAR; HF-GENERATORS

Model Number WA00014A

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 07/27/2021

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 consultant'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 a therapeutic transurethral resection in saline (turis) procedure, the hf-cable sheared off and delivered an electric shock to the consultant.The consultant's injuries were sore but she could finish the procedure with a similar device.No further information was provided.

Manufacturer Narrative

Additional information: d4 ¿ lot number, h4 ¿ device manufacturer date device evaluation: the suspect medical device was returned to the manufacturer for investigation/evaluation.The investigation confirmed that the hf cable is broken.The damage found is a known fault pattern.Age-related wear and tear in connection with repeated great bending and/or tensile loads most likely caused individual or all wires inside the cable to break.When the generator is activated, this can lead to voltage flashovers in the damaged area, which resulted in the formation of sparks and the complete severing of the wires/the connector.According to the article¿s lot number, the hf cable was manufactured in may 2017.It is therefore assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer and thus to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf cable without showing any abnormalities.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 results.

• Brand Name: HF-CABLE, BIPOLAR
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12273239
• MDR Text Key: 266034063
• Report Number: 9610773-2021-00215
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761076449
• UDI-Public: 04042761076449
• 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: 11/02/2021

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: WA00014A
• Device Catalogue Number: WA00014A
• Device Lot Number: 175W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ESG-400 HF-GENERATOR (B)(4).; OLYMPUS UNSPECIFIED RESECTOSCOPE.; OLYMPUS UNSPECIFIED SURGMASTER LOOP.
• Patient Outcome(s): Other