MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETERO- RENOSCOPE; SEMI-RIGID URETEROSCOPE

Model Number 27010KA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Customer indicated that scope did not malfunction and there was no physical issue with it.The sem-rigid scope was returned for microbial testing, since customer believes that scope may have been involved with a patient infection.The rigid endoscope (serial no.(b)(4)) was received one (b)(6) 2018 at karl storz logistic center in (b)(4).Once received, the channels of the endoscope were sampled by performing a flush-brush-flush technique with sterile water and a new cleaning brush to recover any potential contamination inside the device.The sterile water from the channels was collected in a sterile sample cup and a negative control sample was prepared using the same lot of sterile water, cleaning brush, and a sample cup.The sample from the device was labeled as "(b)(4)" while the negative control sample was labeled as "(b)(4)".The samples were then shipped to nelson labs for microbial analysis.Membrane filtration of the samples yielded no detectable colony forming units (cfus).Therefore, no contamination was detected within the channels of the rigid endoscope.

Event Description

Allegedly, the doctor performed a ureteroscopy with left laser lithotripsy and stent placement on a patient.Post procedure, the patient was experiencing fever and chills.Patient went to the er and was found to have an infection and was treated with augmentin- antibiotics.As per the hospital, the patient is recovering well.

• Brand Name: URETERO- RENOSCOPE
• Type of Device: SEMI-RIGID URETEROSCOPE
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7623587
• MDR Text Key: 111815435
• Report Number: 9610617-2018-00043
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 27010KA
• Device Catalogue Number: 27010KA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 88