MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-07 for KARL STORZ 27069K manufactured by Karl Storz Gmbh & Co. Kg.
[15504743]
Allegedly, during a cystoscopy, the tip of the knife broke off in pt. Doctor was unable to retrieve; doctor stated he thought piece would pass through pt with no impact. Procedure completed and pt condition post op was good.
Patient Sequence No: 1, Text Type: D, B5
[15722298]
The hospital sent a picture showing the instrument with the blade broken off; it appears that missing piece is about 2cm in length. The hospital is not releasing the cold knife. Correction: i submitted this mdr to the fda at the end of june. The year listed in the manufacturing and uf/distributor reporting numbers was incorrect. I listed numbers as: 9610617-2010-00027, 2020550-2010-00027. The correct numbers are: 9610617-2011-00027, 2020550-2011-00027.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2011-00027 |
| MDR Report Key | 2163728 |
| Report Source | 06 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-05-17 |
| Date Facility Aware | 2011-06-06 |
| Report Date | 2011-06-30 |
| Date Reported to FDA | 2011-06-30 |
| Date Reported to Mfgr | 2011-06-30 |
| Date Added to Maude | 2012-06-19 |
| 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 Street | MITTLESTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2011-07-07 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-07 |