MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-12 for 11272CU1 manufactured by Karl Storz Endovision.
[52069512]
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) and 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.
Patient Sequence No: 1, Text Type: N, H10
[52069513]
Allegedly, 3 patients were reported to have e-coli infections after use of cystoscope. This report represents patient #2. A urine culture confirmed the infection. The hospital states that the patients were treated with antibiotics and responded well.
Patient Sequence No: 1, Text Type: D, B5
[55714887]
Here is correction: 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 1008009 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.
Patient Sequence No: 1, Text Type: N, H10
[55714888]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2016-00120 |
| MDR Report Key | 5873804 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-12 |
| Date of Report | 2016-07-14 |
| Date of Event | 2016-07-06 |
| Date Mfgr Received | 2016-07-14 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2016-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL ROAD |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11272CU1 |
| Generic Name | CYSTOSCOPE |
| Product Code | FBO |
| Date Received | 2016-08-12 |
| Returned To Mfg | 2016-07-22 |
| Model Number | 11272CU1 |
| Catalog Number | 11272CU1 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-12 |