MAUDE Adverse Event Report: KARL STORZ ENDOVISION FUNKNOWN

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

The model number and serial number were not provided.We, therefore, used product code 'fgb' for this case.This event is filed under internal complaint id (b)(4).

Event Description

As per medwatch report mw5115649 received via email from the fda on 3-20-2023: i had a personal experience of infection with karl storz sales rep endoscope probe via unethical practices.The sales rep (b)(6) uses the medical devices personally against company protocol, he then sells and samples at hospitals (b)(6) and other institutions.Personal use on animals at his home (probes animal orifice), uses the probes in attic and walls for imaging, plays with them with various food and vegetables even rotting, stores them on the floor and in various places against storage and sterilization rules.Patients in urology and mostly women have had infections and emails were sent to his manager karl storz (b)(6).No corrective action or accountability.Can be verified via serial numbers shipped to sales rep (b)(6) and patients with procedures between (b)(6) 2020 to present day.Manual, storage, sterilization procedures are on karl storz website and were not followed in many procedures.

Manufacturer Narrative

Based on the lack of information provided specific to part number and serial number, routine investigation activities could not be performed.Not a manufacturing or design related issue.In addition, based on lack of information provided, additional action cannot be taken.This event is filed under internal complaint id: (b)(4).

• Brand Name: FUNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16769075
• MDR Text Key: 313592914
• Report Number: 1221826-2023-00082
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K141250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

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?: No
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 08/10/2023
• 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): Other