MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SM; ENDOSCOPE SHEATH, REUSABLE

Model Number 27040XB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  Injury  

Event Description

It was reported that there was event with a "inner sheath".According to the information received, the beak tip is broken off in the patient.Unsure, if the broken piece retrieved.Further information is not available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4).Upon the evaluation it could be confirmed that the part of the ceramic beak is broken.In addition, the metal shaft has two dents about 50 mm behind the distal end, this could potential be due to high mechanical force applied.Furthermore, there is a burn mark on the inside of the ceramic beak.The root cause of the breakage is most likely due to mechanical overload causing device to break.The damage of the product is not caused by a production problem or material defect.

• Brand Name: INNER SHEATH, FOR 27040 SM
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• 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: 17261038
• MDR Text Key: 318453769
• Report Number: 9610617-2023-00646
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XB
• Device Catalogue Number: 27040XB
• Device Lot Number: YW01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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