MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22040A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Incontinence (4572)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device was not returned for evaluation, however during a field safety inspection there were no abnormalities or issues found 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 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) / model:a22040a sn: (b)(6)/ model: a22026a sn: (b)(6)/ model: wa22355c sn: unknown (b)(6)/ model: wa00014a sn: (b)(6).This medwatch is for patient identifier (b)(6).

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE (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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18040397
• MDR Text Key: 326981319
• Report Number: 9610773-2023-03123
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Lot Number: 22630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: COLLINS KNIFE; LASER 60W THULIUM LASER, 100W HOLMIUM LASER
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander