MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 5.4 MM, 30°; RIGID OPTICAL LAPAROSCOPE

Model Number WA4KL530

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 01/23/2024

Event Type  Injury  

Event Description

It was reported, the patient had an appendectomy using an unspecified olympus equipment.Three days after, the patient felt pain and went back to the hospital.The patient was treated for an infection and will be returning to the hospital for further treatment.Additional information received that the surgeon told the patient that the appendix was revised in front of the intestine, and it was difficult to get to the appendix that they had to do something different which led to more blood and more chance for infection from the blood that was left over.The patient had another procedure to drain the blood and is recovering.Attempts to obtain additional information from the physician were unsuccessful.

• Brand Name: TELESCOPE "ULTRA", 5.4 MM, 30°
• Type of Device: RIGID OPTICAL LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 18769956
• MDR Text Key: 336131230
• Report Number: 2429304-2024-00117
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2024,02/23/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: WA4KL530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention