MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-02 for SACHSE COLD KNIFE, STRAIGHT 27068K manufactured by Karl Storz Se & Co. Kg.
[188079772]
Per the factory in (b)(6), upon evaluation the blade was found to be broken. There are visible discolorations on the shaft and on the breakage surface. The discoloration indicates corrosion. The broken off part of the blade was not returned. The device was manufactured in august 1989. Therefore it is suspected that the device was in use for more than 30 years. The root cause most probably is wear and tear as the device was manufactured in august 1989. Corrosion can weaken material. Due to wear the blade can get dull which will require higher force initiation during usage. This can cause damage and breakage of the blade. No indication for a manufacturing or material related issue was found during the investigation.
Patient Sequence No: 1, Text Type: N, H10
[188079773]
Per the factory in (b)(6), allegedly there was an event occurred in (b)(6), during a procedure the blade from the optical urethrotome snapped inside the patient. The surgeon was satisfied there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2020-00031 |
| MDR Report Key | 9777121 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 1989-08-01 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2188201 |
| Manufacturer G1 | KARL STORZ SE & CO.KG |
| Manufacturer Street | DR.-KARL-STORZ -STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, GM, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SACHSE COLD KNIFE, STRAIGHT |
| Generic Name | URETHROTOME STRAIGHT COLD KNIFE |
| Product Code | EZO |
| Date Received | 2020-03-02 |
| Model Number | 27068K |
| Catalog Number | 27068K |
| Lot Number | HV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |