MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 7 FR. X 330 MM, FLEXIBLE; ENDOSCOPE AND ACCESSORIES

Model Number O0121

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, that the grasping forceps had a damaged (bent) tube.The malfunction was identified during reprocessing.There was no patient harm associated with the event.

Manufacturer Narrative

The malfunction was confirmed during a physical check by the field service engineer.The device was mechanically damaged, probably due to excessive force.No other faults found.The device was scrapped and will not be returned to olympus.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the cause of the bent shaft was due to external force exerted by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, 7 FR. X 330 MM, FLEXIBLE
• Type of Device: ENDOSCOPE AND ACCESSORIES
• 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: 17661760
• MDR Text Key: 322398126
• Report Number: 9610773-2023-02406
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761000130
• UDI-Public: 04042761000130
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: O0121
• Device Lot Number: 20YW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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