MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-19 for KARL STORZ LAPARASCOPE 26003AA manufactured by Karl Storz Gmbh & Co. Kg.
[220200]
Pt checked into emergency room the day after a lap chole procedure with sepsis. Diagnostic procedure found colon perforation at mid-transverse colon. Colotomy was performed and a section of colon was removed. Pt is doing fine now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2001-00022 |
| MDR Report Key | 357476 |
| Date Received | 2001-10-19 |
| Date of Report | 2001-10-17 |
| Date of Event | 2001-09-07 |
| Date Facility Aware | 2001-09-25 |
| Report Date | 2001-10-17 |
| Date Reported to FDA | 2001-10-18 |
| Date Reported to Mfgr | 2001-10-18 |
| Date Added to Maude | 2001-10-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ LAPARASCOPE |
| Generic Name | TELESCOPE |
| Product Code | ENZ |
| Date Received | 2001-10-19 |
| Model Number | 26003AA |
| Catalog Number | 26003AA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 346697 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-10-19 |