MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 5.4 MM, 0°; RIGID OPTICAL LAPAROSCOPE TELESCOPE

Model Number WA4KL500

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

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation , the objective window found with distal end sagging out.The outer tube was found with dent on the outer tube.The reported issue was confirmed.In addition, inspection found the optical fibers had a broken optical lenses.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported the device was found broken on distal tip.The issue found during reprocessing.There was no patient involvement on this reported event.No harm was reported.No user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2 (also selected ¿health professional¿ which was inadvertently left off the initial report).The customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "ULTRA", 5.4 MM, 0°
• Type of Device: RIGID OPTICAL LAPAROSCOPE TELESCOPE
• 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: 16704822
• MDR Text Key: 312954999
• Report Number: 9610773-2023-01004
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761082877
• UDI-Public: 04042761082877
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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: WA4KL500
• Device Catalogue Number: WA4KL500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• 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