MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-15 for REPROCESSED BIOPSY FORCEPS 1333 manufactured by Sterilmed, Inc..
[1444072]
A reprocessed biopsy forceps was reported to tear the pt's colon during a procedure. There was no reported adverse impact on the pt.
Patient Sequence No: 1, Text Type: D, B5
[8426255]
A thorough investigation of the device in question was conducted and the root cause of the alleged failure could not be identified. The device was visually inspected, and also was tested for functionality, using the standard biopsy forceps performance test methods and the device met all of the acceptance criteria. There was no pt injury reported with the event, but sterilmed will continue to monitor this case and will make fda aware of any adverse health events associated with this situation should any arise. Sterilmed's method of reprocessing biopsy forceps involves thorough inspection for any irregularity that may have the potential to compromise device performance prior to shipment to the customer. The nature of this event has been reported in the maude database by other mfrs before, and is often attributed to improper use of the device by the health care practitioner.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2010-00001 |
| MDR Report Key | 1588897 |
| Report Source | 06 |
| Date Received | 2010-01-15 |
| Date of Report | 2010-01-15 |
| Date of Event | 2009-12-02 |
| Date Mfgr Received | 2009-12-15 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-08-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GARRETT AHLBORG |
| Manufacturer Street | 11400 73RD AVE. N. |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883483 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPROCESSED BIOPSY FORCEPS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | NLU |
| Date Received | 2010-01-15 |
| Returned To Mfg | 2009-12-15 |
| Model Number | 1333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-15 |