MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-10-15 for REPROCESSED ETHICON TX60B OPEN LINEAR STAPLER manufactured by Sterilmed, Inc..
[706761]
User had great difficulty loading the reload cartridge into the device. Once loaded the device misfired into the bowl after several attempts to fire with no results.
Patient Sequence No: 1, Text Type: D, B5
[8120566]
The investigation yielded two possible causes that may have led to the issue. One possibility is a problem with the reload cartridge itself. There may have been a flaw in the cartridge making it difficult to load and subsequently misfire. Sterilmed does not supply reload cartridges with reprocessed open linear staplers. Another possibility lies within the device. When the release button is pushed the closing handle trigger should return to its normal position. This action is designed to bring the lower jaw of the device down into the correct position to accept a reload. If the lower jaw is not completely into position a reload can be forcibly loaded into the device, however it will not be seated properly. If this is the case the retaining pin will not seat properly into the anvil and can result in improperly formed staples. During the sterilmed investigation the jaws returned to their normal position without incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2007-00014 |
| MDR Report Key | 928756 |
| Report Source | 99 |
| Date Received | 2007-10-15 |
| Date of Report | 2007-10-15 |
| Date of Event | 2007-09-20 |
| Date Mfgr Received | 2007-09-20 |
| Device Manufacturer Date | 2007-01-16 |
| Date Added to Maude | 2008-01-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENNIS TOUSSAINT |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPROCESSED ETHICON TX60B OPEN LINEAR STAPLER |
| Generic Name | REPROCESSED OPEN LINEAR STAPLER |
| Product Code | NLL |
| Date Received | 2007-10-15 |
| Returned To Mfg | 2007-09-28 |
| Model Number | TX60B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 940793 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN 55369 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-15 |