MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-15 for HOPKINS STRAIGHT FORWARD TELESCOPE 30? 26046BCA manufactured by Karl Storz Se & Co. Kg.
[175271875]
Per the hospital, they have followed up with both patients and made them aware of the incident and have prescribed antibiotics for them. The hospital also reports that both patients were released from the hospital and they are doing well. Also, per the hospital, neither patient is considered a high-risk patient, and both incidents are now being followed up and monitored by their infection disease and prevention experts.
Patient Sequence No: 1, Text Type: N, H10
[175271876]
Our on-site endoscopic specialist reported that during two separate procedures on (b)(6) 2019 (a laparoscopic cholecystectomy and a laparoscopic appendectomy), an unsterilized scope was mistakenly used on patients in both cases. This report is for the lap chole procedure; a separate report will be filed for the lap appendectomy procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2019-00122 |
| MDR Report Key | 9593883 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2017-11-23 |
| Date Added to Maude | 2020-01-15 |
| 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 SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOPKINS STRAIGHT FORWARD TELESCOPE 30? |
| Generic Name | 30? TELESCOPE |
| Product Code | OWN |
| Date Received | 2020-01-15 |
| Model Number | 26046BCA |
| Catalog Number | 26046BCA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-15 |