MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A42011A

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported to olympus that the buckle of the outer sheath broke resulting in poor sealing and leakage of plasma fluid during a therapeutic plasma hysterotomy.Due to the inability to immediately replace the device during the surgery, the nurse manually assisted in completing the surgery, resulting in minor mucosal tear to the uterine cavity with a little bleeding and no organ tear.There was no intervention required and the procedure was completed successfully without delay.The patient has recovered and been discharged.This mdr is being submitted for the inner tube sheath, resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the cause for the reported issue is likely traced to the outer sheath captured in patient identifier (b)(6).The sheath (model #a42011a) in this complaint was not related to the reported issue because it did not contain any buckle.Furthermore, the device was sent for a third-party repair and not returned to olympus for an inspection.Olympus does not recommend third-party repair actions at unauthorized service centers.After third-party repair, the product may not meet specifications anymore which may place patients and users at risk.This supplemental report includes a correction to a1 and g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17649651
• MDR Text Key: 322258345
• Report Number: 9610773-2023-02391
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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
• Device Operator: Health Professional
• Device Model Number: A42011A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/04/2023
• 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: A22001A (RIGID ENDOSCOPE TELESCOPE); A42021A (ENDOSCOPE SHEATH, REUSABLE); WA22367A (RIGID ENDOSCOPE WORKING GUIDE)
• Patient Sex: Female