MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-19 for CONMED 134006 manufactured by Conmed Corp..
[19957948]
During a laparotomy, a co hand control malleable abc handpiece was used with the argon beam coagulator. After difficulty with the first handpiece a second handpiece wa used. A spark was noted at the gap between the bendable wand & the handpiece. A pen hole sized opening was visualized at the point the bendable wand attaches to the handpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 78312 |
| MDR Report Key | 78312 |
| Date Received | 1997-03-19 |
| Date of Report | 1997-02-26 |
| Date of Event | 1997-02-20 |
| Date Facility Aware | 1997-02-20 |
| Report Date | 1997-02-28 |
| Date Added to Maude | 1997-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | CONMED |
| Generic Name | BEND-A-BEAM 6IN HAND CONTROL MALLEABLE ABC HANDPIECE. |
| Product Code | HQP |
| Date Received | 1997-03-19 |
| Model Number | NA |
| Catalog Number | 134006 |
| Lot Number | J86373A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77940 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 310 BROAD ST UTICA NY 13501 US |
| Baseline Brand Name | CONMED BEND-A-BEAM ABC HANDPIECE |
| Baseline Generic Name | ABC HANDPIECE |
| Baseline Model No | NA |
| Baseline Catalog No | 134006 |
| Baseline ID | NA |
| Baseline Device Family | ABC UNITS AND ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961505 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-03-19 |