MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A20710A

Device Problems Fracture (1260); Difficult to Advance (2920); Difficult to Open or Close (2921)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

[sus voluntary event report # mw5093593.Pdf].

Event Description

Mw5093593 was received by the importer.It was reported that during a lithotripsy, the device caused a fracture of the inner resectoscope element ceramic tip which resulted in retained foreign bodies.The grasper became stuck open and could not be removed easily through the resectoscope lumen.Removal of the grasper was able to be accomplished only after gently rotating the instrument within the resectoscope sheath.The fracture was suspected to likely be due to traction required to pull the lithotrite through the resectoscope.Some of the residual foreign body fragments were grasped and removed, but several pieces remained.Cystoscopic removal was required four days later.Radiographic confirmation of complete foreign body removal was performed at the end of the case.As no lot number was provided we are unable to complete a device history record review.Customer information was not provided in mw5093593.The device has not been received for evaluation, therefore we are unable to determine the root cause of the grasper being stuck open.

Event Description

This report is being supplemented to provide additional information (b5) regarding the reported event.Based on the information provided, it was determined the root cause of the reported event is a use/user error due to excessive force.It was concluded the overload safety device was triggered-the forceps remain open.As no dhr review could be completed due to no serial/lot number being provided, manufacturing and quality control review was performed for the last 24 months of production.No non-conformance or deviation regarding the described issue was found.Olympus surgical technologies of europe will continue to monitor the occurrence rate in the context of our quality management system.If necessary, we will take further action in the future.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9993063
• MDR Text Key: 188795800
• Report Number: 2951238-2020-00430
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/07/2020,08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention