MAUDE Adverse Event Report: KARL STORZ ENDOVISION 11272CU1; CYSTOSCOPE

Model Number 11272CU1

Device Problems Contamination /Decontamination Problem (2895); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Bacterial Infection (1735)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

There were 2 scopes involved, but the user site could not determine which one was used on which patient; so we are providing evaluations for both scopes.Evaluation of scope w/sn (b)(4).The evaluation results for endoscope s/n (b)(4) concluded the primary damage to result from punctures in the proximal thread wrap, which lead to endoscope damage from a leak.Other notable observations included debris at the handle housing screw, debris at the distal window surface, debris at the distal head surface and vertebrae system, and elongation at 10 mm from the distal tip due to a master sheathing bond failure which included debris at the surface.The endoscope failed the leak test.Em evaluation of scope w/sn (b)(4).The evaluation results for endoscope s/n (b)(4) concluded the primary damage to result from a cut in the angle cover 5mm from the distal tip, which lead to endoscope damage from a leak.Other notable observations included debris at the housing surface, 3rd party repair at the shaft, debris on and inside the distal window, scrape marks with a lifted channel wall, a partially blocked channel, and debris at the shaft surface, distal head surface, and vertebrae system.The endoscope failed the leak test.Conclusion: evaluation of the karl storz flexible cystoscopes model 11272cu1, s/n (b)(4), showed significant signs of damage as well as visible debris in multiple locations.The use of a damaged endoscope during a procedure poses a risk to patient safety, including the possibility for infection.This is also true for residual debris left on an endoscope following reprocessing.Adhering to manufacturer's instructions for use is critical for ensuring that these risks are prevented.On-site evaluation of the reprocessing procedures at the facility showed practices that may not have prevented these risks and this was confirmed upon the evaluation by karl storz endovision.Since the channel is not visible to the naked eye, the account requested that we provide instructions to extract microorganism samples from the lumen so they could perform tests of the scope.We learned that the e-coli test result was negative.Although no contamination was confirmed, the complete investigation indicated that damaged endoscopes in conjunction with inadequate reprocessing could have contributed to the endoscope related infections.

Event Description

Allegedly, 3 patients were reported to have e-coli infections after use of cystoscope.This report represents patient #3.A urine culture confirmed the infection.The hospital states that the patients were treated with antibiotics and responded well.

Manufacturer Narrative

In the original mdr, we provided this evaluation on this scope: em evaluation of scope w/sn (b)(4) the evaluation results for endoscope s/n (b)(4) concluded the primary damage to result from a cut in the angle cover 5mm from the distal tip, which lead to endoscope damage from a leak.Other notable observations included debris at the housing surface, 3rd party repair at the shaft, debris on and inside the distal window, scrape marks with a lifted channel wall, a partially blocked channel, and debris at the shaft surface, distal head surface, and vertebrae system.The endoscope failed the leak test.After further review it was determined that there was no 3rd party repair done on this scope.Here is the correct evaluation with 3rd party statement removed: em evaluation of scope w/sn (b)(4) the evaluation results for endoscope s/n (b)(4) concluded the primary damage to result from a cut in the angle cover 5mm from the distal tip, which lead to endoscope damage from a leak.Other notable observations included debris at the housing surface, debris on and inside the distal window, scrape marks with a lifted channel wall, a partially blocked channel, and debris at the shaft surface, distal head surface, and vertebrae system.The endoscope failed the leak test.

Event Description

• Brand Name: 11272CU1
• Type of Device: CYSTOSCOPE
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 5873811
• MDR Text Key: 52058344
• Report Number: 1221826-2016-00121
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2016

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 Operator: Physician
• Device Model Number: 11272CU1
• Device Catalogue Number: 11272CU1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2010
• 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: 72 YR