MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE 15FR X 37MM ADULT

Model Number 11272CK2

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

We could not obtain any additional information from the customer.The scope was returned and found over bend of the passive section of the vertebrae system and the marker rings on shaft are discolored yellow.Additionally, the taper assembly is burnt.The facility received the product on 02/20/2020.The endoscope has been sampled for testing and sent to the laboratory and are waiting for results.

Event Description

Allegedly per the customer, reports of bacterial infections occurred post-operative on several occasions during the months of (b)(6) 2020.

Manufacturer Narrative

The endoscope was sampled to determine if contamination was present in the channel when returned from the customer.The results of the sample identified three microorganisms, where only one of which, chryseobacterium, is potentially considered of high concern based on morphology(i.E.Gram negative, rod).Each mocroorganism grew in low numbers with 1 colony forming unit(cfu) being recorded per isolate.It could not be confirmed whether the organisms identified match those linked to patient infections as this information was not provided.The organisms of low concern, micrococcus luteus and dermacoccus nishinomiyaensis, most likely resulted from an external source of contamination(e.G.Laboratory sampling)based on their typical environmental source (e.G.Human skin).Although laboratory tests performed on the returned products identified a single high concern organism following return to karl storz, no microbiological contamination were identified after standard reprocessing.This indicates that there may be gaps in the existing repocessing methods by the customer.Standard reprocessing as performed in the evaluation center at kse-charlton resolved the contamination and indicates that no major contamination issues/biofil formation is present.Compliance with the standard, validated procedure for reprocessing of karl storz flexible endoscopes ensures patient safety.Based on this investigation, this scope passed all outgoing inspection requirement and the device history record did not contain any anomalies that would contribute to the failure in the field.The ifu has statements regarding proper disinfection and sterilization of the device prior to use.

• Brand Name: CYSTOSCOPE 15FR X 37MM ADULT
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 10288902
• MDR Text Key: 199989023
• Report Number: 9610617-2020-00080
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• PMA/PMN Number: K945185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11272CK2
• Device Catalogue Number: 11272CK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention