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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.As no lot/serial number was provided we are unable to complete a device history record review.Customer information was not provided in mw5093593.Therefore we are unable to determine the root cause of the grasper being stuck open.This event has been reported by the importer on mdr# 2951238-2020-00430.Sus voluntary event report # mw5093593.
Event or Problem Description
Mw5093593 was received by the manufacturer.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information (h6, h10) 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
• Common Device Name: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9993133
• Report Number: 9610773-2020-00107
• Device Sequence Number: 17253912
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention