MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 24 FR.

Model Number 27040BO

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

Patient Problem Easy Bruising (4558)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis but it was reported that all products were functioning as it should have been.It was a case of user error due to a knowledge gap to use the necessary adaptor.The previous reportability decision for this event was reversed based on a retrospective review.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the user placed rigid biopsy forceps into the resection sheath, creating additional length for the instrument to pass beyond the distal end of the sheath.The patient's bladder wall was bruised but not perforated.

• Brand Name: RESECTOSCOPE SHEATH, 24 FR.
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17908920
• MDR Text Key: 325339278
• Report Number: 9610617-2023-00286
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551232583
• UDI-Public: 4048551232583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040BO
• Device Catalogue Number: 27040BO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other