MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number	A22026A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 address: (b)(6).The device was not returned for evaluation, however during a field safety inspection there were no abnormalities or issues with the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The olympus representative reported on behalf of the customer that during a planned laser prostate resection on (b)(6) 2023, a non-olympus laser was being used initially but due to some technical issue with the laser equipment, the doctor used the olympus resection set with a non-olympus knife.After using the device for nearly 20 to 25 minutes, the doctor had shifted to a different non-olympus laser and completed the procedure with no complications at that point.At a later date on (b)(6) 2023, the catheter was removed from the patient and the patient was okay at that time.On (b)(6) 2023, the patient had a follow-up visit and per the doctor the patient was fine.On (b)(6) 2023, the patient noticed a "urine leak" and notified a doctor.On (b)(6) 2023, the operating doctor became aware and received pictures that the patient provided.The doctor advised for a needed urethral reconstruction and no other complications.This event requires 6 reports.Related patient identifiers: (b)(6) / model: wb91051w sn: (b)(6); (b)(6) / model:wa22366a sn: (b)(6); (b)(6) / model:a22040a sn: (b)(6); (b)(6) / model: a22026a sn: (b)(6); (b)(6) / model: wa22355c sn: unknown; (b)(6) / model: wa00014a sn:(b)(6).This medwatch is for patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, since the device was not returned to olympus for evaluation, the reported event was not confirmed.Therefore, the root cause could not be determined.This supplemental report includes additional information received from the customer.B5 updated accordingly.A correction has been made to g2 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the patient is ¿doing fine and in the recovery phase." the decision of the urethral reconstruction was not pursued further.Per the facility, the reported event was not caused by an olympus device.It was confirmed that the same devices and accessories have been used in subsequent procedures without issue.

• Brand Name: OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
• Common Device Name: ENDOSCOPE, AC-POWERED 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: 18040481
• Report Number: 9610773-2023-03124
• Device Sequence Number: 15268848
• Product Code: GCP
• UDI-Device Identifier: 04042761029346
• UDI-Public: 04042761029346
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: A22026A
• Device Lot Number: 141W-0054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• 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: COLLINS KNIFE; LASER 60W THULIUM LASER, 100W HOLMIUM LASER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander