MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-06-18 for KARL STORZ VERESS NEEDLE 26186J manufactured by Karl Storz Gmbh & Co..
[95422]
During a diagnostic laparoscopy procedure when the veress needle was inserted into the pt, the shaft of the needle snapped off. Unaware that the shaft was broken, the doctor inserted a telescope into the cannula and pushed the shaft in. Open surgery was performed. No perforation was found and the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1998-00015 |
| MDR Report Key | 173286 |
| Report Source | 05,06 |
| Date Received | 1998-06-18 |
| Date of Report | 1998-06-16 |
| Date of Event | 1998-05-20 |
| Date Facility Aware | 1998-05-21 |
| Report Date | 1998-06-16 |
| Date Reported to FDA | 1998-06-17 |
| Date Reported to Mfgr | 1998-06-17 |
| Date Added to Maude | 1998-06-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ VERESS NEEDLE |
| Generic Name | VERESS NEEDLE |
| Product Code | FHP |
| Date Received | 1998-06-18 |
| Model Number | 26186J |
| Catalog Number | 26186J |
| Lot Number | GN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 168481 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503 |
| Baseline Brand Name | KARL STORZ VERESS NEEDLE |
| Baseline Generic Name | VERESS NEEDLE |
| Baseline Model No | 26186J |
| Baseline Catalog No | 26186J |
| Baseline ID | * |
| Baseline Device Family | TROCAR AND CANNULA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951190 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-18 |