MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-05 for KARL STORZ 8590J manufactured by Karl Storz Gmbh & Co. Kg.
[138321]
The data and info contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting. This mdr is based on preliminary info received by karl storz, who has not conclusively determined the cause of the adverse event. This mdr is, therefore, not intended to and shall not constitutue an admission that a reportable event occurred or that any karl storz product was causally related to the incident. During a laparoscopy procedure a karl storz laryngoscope was allegedly used. It tore the lateral pharyngeal wall and required suturing to repair the damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2001-00003 |
| MDR Report Key | 311085 |
| Date Received | 2001-01-05 |
| Date of Report | 2001-01-05 |
| Date of Event | 2000-11-29 |
| Date Facility Aware | 2000-12-04 |
| Report Date | 2001-01-04 |
| Date Reported to FDA | 2001-01-04 |
| Date Reported to Mfgr | 2001-01-01 |
| Date Added to Maude | 2001-01-09 |
| 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 |
| 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 |
| Generic Name | LARYNGOSCOPE |
| Product Code | ENZ |
| Date Received | 2001-01-05 |
| Model Number | 8590J |
| Catalog Number | 8590J |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 300913 |
| 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 | 2001-01-05 |