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.

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2024-00117.The subject device model and serial numbers are unknown.Olympus selected "wa4kl530" as a representative product for processing purposes.Attempts to obtain additional information from the physician were unsuccessful.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

• 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
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18770276
• MDR Text Key: 336181365
• Report Number: 9610773-2024-00519
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/23/2024
• 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
• Patient Outcome(s): Required Intervention