MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-12-19 for KARL STORZ 11301BN1 NA manufactured by Karl Storz Endovision.
[4218273]
Allegedly, based on a vigilance report filed with (b)(4) by our parent company in (b)(6), 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 #3.
Patient Sequence No: 1, Text Type: D, B5
[11365623]
After the events, (b)(4) university 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221826-2013-00054 |
| MDR Report Key | 3565553 |
| Report Source | 01,06,07 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-20 |
| Date of Event | 2013-11-15 |
| Date Mfgr Received | 2013-11-20 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-01-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSIE CHEN, COMPLAINT |
| Manufacturer Street | 2151 E. GRAND AVE. |
| 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 RD. |
| 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 | KARL STORZ |
| Generic Name | INTUBATION SCOPE |
| Product Code | CAL |
| Date Received | 2013-12-19 |
| Model Number | 11301BN1 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | CHARLTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-12-19 |