MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE; OPTICAL FORCEPS

Model Number A20710A

Device Problems Break (1069); Difficult to Fold, Unfold or Collapse (1254)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed due to the jaw insert and locking mechanism malfunctioning.The welded connection between the pull-wire guide and the pull-wire of the forceps, which functions as overload protection, was broken or the forceps overload protection has been properly triggered as a result of a massive overload in order to prevent an axle breakage or similar damage in the jaw area.Forceps with triggered overload protection are non-functional and do not comply with the current product specification and cannot be further used according to the " intended use ".Important information: to prevent damage of this nature, product quality information (pqi) no.07/12 "punch for bladder stones" was published in july 2015 and design changes were implemented to prevent possible blockage of the jaw after the overload protection has been properly triggered.The device in question was manufactured after october 2015 which means that until this date there was a possibility that the jaws remained open due to the application of excessive force on the overload protection.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The investigation concluded that the reported problem was likely the function of the forceps being tested and the overload protection was properly triggered as a result of a massive overload and improper handling.The reason the overload protection was already triggered before the first use cannot be determined.Olympus will continue to monitor field performance for this device.A follow up with the user facility is currently being performed.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

An olympus salesperson reported on behalf of the customer, the working end of grasping forceps, optical, for lithotripsy, for 12°and 30°telescope does not close when it is with a load.The subject device malfunctioned upon initial use.There was no report of patient involvement or harm associated with this event.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE
• Type of Device: OPTICAL FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15906408
• MDR Text Key: 308079639
• Report Number: 9610773-2022-00579
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: 22501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1