MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS ESG-100, 220...240 V~,; HF-GENERATORS

Model Number WB991036

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The suspect medical devices were not returned to olympus for evaluation/investigation.There were no reports of any malfunction of the respective hf-generators during the procedures performed.Therefore, the exact cause of the reported phenomena and the patient¿s outcomes could not be determined and is being judged as unknown.Furthermore, a dhr review could not be performed since basic data of article identification (serial number) are missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.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 result.

Event Description

In the course of general literature search at olympus, a study entitled "endoscopic full-thickness resection(ftr) versus endoscopic submucosal dissection (esd) in the treatment of colonic neoplastic lesions = 30 mm¿a single-center experience"was reviewed that was conducted at vítkovice hospital in ostrava and university hospital in olomouc, czech republic.The study describes complications that occured in patients in connection with the respective procedures, which were performed using the olympus esg-100 or esg-300 hf generators in the time period between march 2015 and september 2018.Since the literature specifies both the esg-100 generator and the esg-30 generator, the esg-100 hf generator has been selected as a representative product.The study describes that during the ftr procedures performed perforation occured in 1 patient, delayed bleeding in 4 patients and acute appednicitis in 2 patients.During the esd procedures performed perforation occured in 4 patients, delayed bleeding in 4 patients, and coagulation syndrome in 12 patients.There was no report about any malfunction of any of the olympus medical devices used.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• 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 14513 ; GM 14513
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14797957
• MDR Text Key: 294651089
• Report Number: 9610773-2022-00237
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB991036
• Device Catalogue Number: WB991036
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OLYMPUS DISPOSABLE DISTAL ATTACHMENT D-201-14304; OLYMPUS EVIS EXERA II COLONVIDESCOPE CF-H180AL; OLYMPUS EVIS EXERA III COLONOSCOPE PCF-H190DL/I; OLYMPUS EVIS EXERA III COLONSCOPE CF-HQ190L/I; OLYMPUS ROTABLE CLIP FIXING DEVICE HX-110UR; OLYMPUS SINGLE USE ELECTROSURG. FORCEPS FD-411UR; OLYMPUS SINGLE USE ELECTROSURGICAL KNIFE KD-650U; OLYMPUS SLIM COLONOSCOPE PCF-H190TL/I; OLYMPUS SU ROTABLE CLIP FIXING DEVICE HX-201YR-135
• Patient Outcome(s): Required Intervention