MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SCISSORS, 5 FR., SEMIFLEXIBLE

Model Number	A4826
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the scissors, 5 fr., semiflexible to olympus repair center for evaluation of a reported broken insertion part that was found during preparation for use for a diagnostic, hysteroscopy procedure.The procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device evaluation found the insertion tube of the subject instrument ruptured from the root (the working end of the grasping forceps is completely broken off.That means the jaws are not connected to the shaft anymore).There is tearing at the broken part of the insertion tube.The insertion tube has multiple bends and deformations.Inspection noted that the tearing phenomenon at the fracture position of the insertion tube caused by external force.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section b5 was corrected with information that was inadvertently omitted from the initial report.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, the definitive root cause of the broken insertion part was external force.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The patient was not under anesthesia.

• Brand Name: SCISSORS, 5 FR., SEMIFLEXIBLE
• Common Device Name: SCISSORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17210648
• Report Number: 9610773-2023-01740
• Device Sequence Number: 5684182
• Product Code: NWW
• UDI-Device Identifier: 04042761006897
• UDI-Public: 04042761006897
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: A4826
• Device Catalogue Number: A4826
• Device Lot Number: 229W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2023
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OTV-S190
• Patient Sex: Unknown