MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR "ESG-410"; HF-GENERATORS

Model Number WA91307W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 01/11/2022

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 a therapeutic transurethral resection of the prostate (turp) procedure that was performed under spinal anesthesia, the surgeon heard an explosion sound in the bladder and the patient reported to feel pain.The surgeon then detected a lesion in the bladder wall.The intended procedure was not completed but interrupted and a bladder catheter was placed.No further information was provided.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to the olympus regional repair center (rrc) (b)(4) czech republic (received at the rrc on 2022-02-02).Apart from a superficial scratch on the hf-generator¿s housing, which has no causal relationship to the reported incident, the evaluation at the repair center did not reveal any malfunctions of the hf-generator but found the device to be working correctly.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the hf-generator without showing any abnormalities.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be conclusively determined.However, since the hf-generator was evaluated as in standard, the reported event/incident can in all likelihood be attributed to use error.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13287979
• MDR Text Key: 289181650
• Report Number: 9610773-2022-00055
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761086332
• UDI-Public: 04042761086332
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K203277
• 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
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA91307W
• Device Catalogue Number: WA91307W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male