MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400" HF-GENERATORS

Model Number WB91051C

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

Patient Problem Death (1802)

Event Date 07/04/2019

Event Type  Death  

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. Please note: this report is being submitted although the suspect medical device is not marketed in the usa. However, a similar device is marketed. Model # / catalog #: wb91051w; brand name: hf unit "esg-400"; common device name: hf-generators; 510(k): k141225; product code: gei.

Event Description

Olympus was informed that one day after a therapeutic transurethral resection of the prostate (turp) procedure, the patient was transferred to icu and passed away due to massive hemorrhage. The user facility reported that the hemostasis was poor intraoperatively. However, the turp was completed with the same set of equipment. An on-site investigation on (b)(6) 2019 revealed that the hf cables of the generator and spare generator (ues-40) did not function correctly related to contact quality and electricity leakage. No further information was provided.

• Brand Name: HF UNIT "ESG-400"
• 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: 8844795
• MDR Text Key: 152747279
• Report Number: 9610773-2019-00096
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (Y/N): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/31/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: WB91051C
• Device Catalogue Number: WB91051C
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/20/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 07/31/2019 Patient Sequence Number: 1

Treatment

OLYMPUS SURGMASTER ELECTROSURGICAL UNIT (UES-40); OLYMPUS UNSPECIFIED HF CABLES