MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. KARL STORZ INTUBATION SCOPE

Model Number 11301BN1

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802); Unspecified Infection (1930)

Event Date 11/15/2013

Event Type  Death  

Event Description

The data and information contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting. This mdr is based on preliminary information received by karl storz, who has not conclusively determined the cause of the adverse event. This mdr is, therefore, not intended to and shall not constitute an admission that a reportable event occurred or that any karl storz products were caused related to the incident. Allegedly, based on a vigilance report filed with (b)(6) by our parent company in (b)(4), 5 patients became infected with klebsiella pneumoniae microbes after intubations done with this scope. Three patients expired after being infected, although there is no causal link established between infection and outcome. Outcome of 2 other infected patients unknown. We will list patients who expired as patient #1, #2, and #3. The 2 patients who were infected but did not expire, are listed as patients #4 and #5. This report is regarding patient #1.

Manufacturer Narrative

After the events, (b)(6) hospital's testing results confirmed that scope contained resistant microbes (klebsiella pneumoniae). Our investigation of events confirmed that an incorrect, undersized cleaning brush was used on the scope before olympus aer high level disinfection process. Hospital was informed regarding correct cleaning brush. The hospital replaced this brush with the correct sized cleaning brush and processed scope again. Scope was tested afterwards by hospital's infection control department for bacteria; results were negative. Karl storz-(b)(4) evaluation: the flexible endoscope was delivered to karl storz (b)(4) on (b)(4). Upon investigation, we couldn't find any damages or leakages. The instrument channel shows no deformations, scratches or other damages that could trap debris as a potential root cause. There is no indication detectable that the endoscope itself was the root cause of the infections. After appropriate reprocessing according to the ifu, the endoscope is free of microorganism. The device will be sent back to manufacturer.

• Brand Name: KARL STORZ
• Type of Device: INTUBATION SCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; charlton MA
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill rd.; charlton MA 01507
• Manufacturer Contact: susie chen, complaint ; 2151 e. grand ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 3565551
• MDR Text Key: 4217799
• Report Number: 1221826-2013-00052
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 11301BN1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/19/2013 Patient Sequence Number: 1