MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 3 FR., FOR STONE FRAGMENTS, FLEXIBLE; FLEXIBLE GRASPING FORCEPS

Model Number	A2580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Event or Problem Description
Olympus (oekg) was informed that the customer flexible grasping forceps for stone fragments was returned to the olympus service department for a reported ¿broken, foreign material¿.The customer reported problem was found at an unspecified event.The initial inspection found a part of the working end is broken, there is no connection to the jaw and the grasper is non-functional.No death or injury and no impact to patient or other has been reported to olympus.The device will be forwarded to the regional repair center.
Additional Manufacturer Narrative
This supplemental report was submitted to provide the results of the investigation performed by the legal manufacturer.The device history records (dhr) was performed for the affected lot number without showing any non-conformities or deviations regarding the described issues.The legal manufacturer¿s (oste) investigation determined that there is no design, manufacturing, material or processing related cause for the reported event.No device was returned for evaluation.The service evaluation of the device confirmed the forceps are broken but could not confirm foreign material or corrosion at the forceps.Based on the information , the cause of the broken forceps is potentially due to excessive force exerted on the device, in combination with twisting the forceps at the same time.Olympus will continue to monitor complaints related to the device and reported phenomenon.

• Brand Name: GRASPING FORCEPS, 3 FR., FOR STONE FRAGMENTS, FLEXIBLE
• Common Device Name: FLEXIBLE GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16192585
• Report Number: 9610773-2023-00251
• Device Sequence Number: 6006666
• Product Code: GCP
• UDI-Device Identifier: 04042761003742
• UDI-Public: 04042761003742
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: A2580
• Device Catalogue Number: A2580
• Device Lot Number: 203W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown