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

Model Number A22040A

Device Problems Break (1069); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.There was no lot number provided therefore, a 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.The instruction for use (ifu) warns before use make sure that the product has been properly reprocessed, inspected, and tested.A damaged sheath can cause injury to the urethra.If the obturator¿s distal end does not move when inserted into the patient, do not try to remove the obturator from the sheath.Remove the entire sheath/obturator assembly from the patient.Otherwise, the sheath¿s distal end may be damaged.If the device is returned or additional information is obtained, a supplemental report will be filed accordingly.Other 510k number = k931995.

Event Description

The manufacturer was informed that during a cystoscopy, ureteropyelogram, bladder biopsy with evacuation of clots, a portion of the inner sheath tip broke off inside of the patient.The piece of the device was fully retrieved by the physician.There was no patient injury reported.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 8873493
• MDR Text Key: 199739542
• Report Number: 9610773-2019-00107
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 40