MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 10 MM, 30°; TELESCOPE RIGID OPTICAL LAPAROSCOPE

Model Number WA4KL130

Device Problems Break (1069); Crack (1135); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

Field service engineer (fse) company representative in behalf of the customer reported the device was falling down during the reprocessing and found some parts were broken.There was no patient involvement on this reported event.No user injury was reported.

Manufacturer Narrative

The subject device was received and evaluated at sbc olympus thailand repair center.Device evaluation found mechanical damage , crack on the lens surface was observed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

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 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely the reported damage occurred due to improper handling by the user.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "ULTRA", 10 MM, 30°
• Type of Device: TELESCOPE 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16753019
• MDR Text Key: 313435744
• Report Number: 9610773-2023-01054
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761082853
• UDI-Public: 04042761082853
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K150633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA4KL130
• Device Catalogue Number: WA4KL130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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