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

Model Number	WA91307W
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patients' 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 or Problem Description
Olympus was informed that during and after several therapeutic prostate resection procedures performed at the same hospital over a period of approx.6 weeks in (b)(6) 2021, the operating surgeons reportedly noted several issues/defiencies with their new esg-410 hf-generator unit in comparison with their previous hf generator setup.They felt a reduced coagulation capacity with vessels reopening after the haemostatic action both during cutting and coagulation.Furthermore, the surgeons reported that they felt it took longer to clot/coagulate prostate adenoma, that there was a greater prostatic irritation, longer hospital stays (prolonged catheterizations due to low tissue haemostasis), and in some cases the necessity of blood transfusions.
Additional Manufacturer Narrative
Additional information: b1 - report type, b5 - describe event or problem device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation did not reveal any malfunctions of the hf-generator but found the device to be working correctly.No abnormality, defect, failure or malfunction could be determined.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 patients' outcome could not be conclusively determined.However, since the generator was evaluated as in standard, the reported events/incidents can in all likelihood be attributed to use error.The case will be closed on olympus side with no further actions.The reported events/incidents will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
Event or Problem Description
Olympus was informed that during and after a total of five therapeutic prostate resection procedures performed at the same hospital over a period of approx.6 weeks in (b)(6) 2021, the operating surgeons reportedly noted several issues/defiencies with their new esg-410 hf-generator unit in comparison with their previous hf generator setup.They felt a reduced coagulation capacity with vessels reopening after the haemostatic action both during cutting and coagulation.Furthermore, the surgeons reported that they felt it took longer to clot/coagulate prostate adenoma, that there was a greater prostatic irritation, longer hospital stays (prolonged catheterizations due to low tissue haemostasis), and in some cases the necessity of blood transfusions.Please note that this case is a summary complaint referring to a total of five incidents that occurred with the same device at the same hospital.When sufficient information regarding the individual cases had been provided, separate reports were submitted for each patient/incident.Please refer to mfr report numbers: 9610773 - 2021 ¿ 00322, 9610773 - 2021 ¿ 00321, 9610773 - 2021 ¿ 00323, 9610773 - 2021 ¿ 00325, 9610773 - 2021 - 00324.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: 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 ; 4940669662955
• MDR Report Key: 12696031
• Report Number: 9610773-2021-00303
• Device Sequence Number: 11899703
• Product Code: GEI
• UDI-Device Identifier: 04042761086332
• UDI-Public: 04042761086332
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K203277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: WA91307W
• Device Catalogue Number: WA91307W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male