MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH F. RESECT. SHEATH, 15 FR.; RIGID ENDOSCOPE SHEATH, REUSABLE

Model Number 26055CB

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2022

Event Type  Injury  

Event Description

As per manufacturer incident report #(b)(4) received from the factory in germany: the reported event happened in spain.According to the information available, the ceramic tip broke off inside the patient, with a kind of explosion.The physician had to remove the parts from inside the patient without being sure that all parts were collected.There is no further information related to the described explosion.

Manufacturer Narrative

The initial review of the instruments received for analysis does not show signs of explosion; thermal damages and abrasion are visible on the instruments.Investigation is ongoing.

Manufacturer Narrative

The explosion/bang described by the user can only have been caused by the damaged ceramic insert.The investigation showed that the ceramic was damaged by excessive force application.In the course of the missing insulation between the optics and the inner shaft surface, a short circuit subsequently occurred.The distal end shows thermal damage and the ceramic insert is completely broken due to excessive force application.

• Brand Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Type of Device: RIGID ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14685225
• MDR Text Key: 294132092
• Report Number: 9610617-2022-00090
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 4048551275597
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26055CB
• Device Catalogue Number: 26055CB
• Device Lot Number: RO01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2022
• Date Device Manufactured: 04/15/2021
• 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
• Patient Outcome(s): Other