MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "IR", 10 MM, 30°; CONFOCAL OPTICAL IMAGING

Model Number WAIR130A

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

Patient Problems Hemorrhage/Bleeding (1888); Bowel Perforation (2668)

Event Date 02/09/2023

Event Type  Injury  

Event Description

A company representative, on behalf of a user facility, reported to olympus that during a pancreaticoduodenectomy (whipple procedure) using a telescope "ir", 10 mm, 30°, the patient sustained several injuries.The surgeon was using a suture and accidentally cut the patient's hepatic artery as well as punctured the colon while grasping it.The blood loss due to the hepatic artery cut was controlled within a matter of minutes by coagulation.There were no error messages while using our equipment during the procedure.The procedure was expected to last 4-6 hours, but instead lasted 12 hours.The patient was hospitalized in the intensive care unit but was stable a "few days" after the case.It was stated that there was no failure of olympus equipment.Patient identifier (b)(6) is for the telescope "ir", 10 mm, 30°.Patient identifier (b)(6) is for the hd 3cmos autoclavable camera head.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This report was submitted by the importer under the importer's report number: 2429304 - 2023 - 00035.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, this complaint refers to a medical incident.There was no malfunction of the olympus device, and the device did not cause or contribute to the reported event.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "IR", 10 MM, 30°
• Type of Device: CONFOCAL OPTICAL IMAGING
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16507966
• MDR Text Key: 310948139
• Report Number: 9610773-2023-00698
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761083638
• UDI-Public: 04042761083638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WAIR130A
• Device Catalogue Number: WAIR130A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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
• Treatment: HD 3CMOS AUTOCLAVABLE CAMERA HEAD
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White