MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 27 FR.; ENDOSCOPE SHEATH, REUSABLE

Model Number 27241AK

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2018

Event Type  Injury  

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).The ceramic tip is broken off - the fracture surface is without discoloration, the bonding of the tip in the tube is intact.The shaft tube shows lateral deformation.The shaft was destroyed by mechanical overload.Due to the deformation of the tube, a lateral impact can be assumed.The lack of discoloration in the fracture surface suggests a relatively recent fracture.The exact time cannot be determined.The damage cannot be reduced to a material or production defect.

Event Description

It was reported that there was event with a "sheath".According to the information received, the son of a patient who underwent surgery would like opinion on karl storz products used/product error/medical error.Background is an (unreported) intraoperative incident on (b)(6) 2018, in which a ceramic piece of a resectoscope shaft 27241ak broke off distally in the patient's urethra and had to be recovered at great expense.Further information is not available.

• Brand Name: RESECTOSCOPE SHEATH, 27 FR.
• 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: 17263496
• MDR Text Key: 318580523
• Report Number: 9610617-2023-00655
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 27241AK
• Device Catalogue Number: 27241AK
• Device Lot Number: YS01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• 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