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 addi-tional 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
• MDR Report Key: 17908919
• MDR Text Key: 325340459
• Report Number: 2020550-2023-00286
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551232583
• UDI-Public: 4048551232583
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other