MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCALPEL, REUSABLE

Model Number 27068K

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2020

Event Type  Injury  

Event Description

It was reported that there was event with a knife, straight.According to the information received, a 71 year old patient with a distal stenosis.A blind urethrotomy is then performed, the right knife blade of the urethrotome is pushed into the bladder, upstream of the urethral stenosis.Approximately 10 minutes after the start of the procedure, the blade broke and was displaced intravesically.The broken metal part was difficult to recover, causing an increase of 30 minutes in the operating time.This is the first time that such an incident has occurred.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The product in question was not returned to manufacture for investigation, therefore the root cause is unknown.However, based on the internal evaluation, the device breakage could potentially be due to mechanical overload during use i.E.Use error.In case product or new information is available in future, the case will be reopened.The risk level and probability are still adequate.The event is filed under internal karl storz complaint id ((b)(4)).

• Brand Name: SCALPEL, REUSABLE
• Type of Device: SCALPEL, 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: 16950096
• MDR Text Key: 315438163
• Report Number: 9610617-2023-00622
• Device Sequence Number: 1
• Product Code: EZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K934730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27068K
• Device Catalogue Number: 27068K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• 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): Required Intervention