MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 7,5 FR. X 430 MM, 7, 2 CHANNELS, STRAIGHT OCULAR ANGLE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	WA02944A
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for physical evaluation.The facility requested an endoscopy support specialist (ess) to come onsite to perform a reprocessing inservice.While onsite to perform in-servicing, the ess was informed of the event.In-servicing was completed using the complaint device.In-servicing included all cleaning, disinfection, and sterilization information contained in olympus manual.Investigation: the issue reported by the customer was evaluated as plausible.According to the event description, residues of a bladder stone, or kidney stone from a previous procedure remained in the working channel of the affected product.During the next procedure, these residues entered another patient¿s body.Consequently, the reprocessing employees on site were trained.No pictures were provided by the customer.No product-related malfunction or defect was reported.Cause: the cause for the reported issue is very likely improper reprocessing.
Event or Problem Description
It is reported following cleaning and sterilization of an olympus ureteroscope, during use on the next unspecified procedure, a stone was pushed out of the scope from the previous procedure, and into the patient.There was no reported impact to the patient as a result of this occurrence.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is provided in h6, h10.It was not possible to conduct a device history review for the complaint device since the serial number provided was not correct.Instead, the manufacturing and quality control review was performed for the last 24 months of production without showing any non- conformities or deviations regarding the described issue.Analysis: the issue reported by the customer was evaluated as plausible.According to the event description, residues of a bladder stone or kidney stone from a previous procedure remained in the working channel of the affected product.During the next procedure, these residues entered another patient¿s body.Consequently, the reprocessing employees on site were trained.No pictures were provided by the customer.No product-related malfunction or defect was reported.Conclusion: the cause for the reported issue is very likely improper reprocessing.

• Brand Name: URETEROSCOPE, 7,5 FR. X 430 MM, 7, 2 CHANNELS, STRAIGHT OCULAR ANGLE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10900438
• Report Number: 9610773-2020-00278
• Device Sequence Number: 16766564
• Product Code: FGB
• UDI-Device Identifier: 04042761029544
• UDI-Public: 04042761029544
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K951855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: WA02944A
• Device Catalogue Number: WA02944A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1