MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-11-23 for REPROCESSED COLD BIOPSY FORCEPS 1599 manufactured by Sterilmed, Inc..
[2949426]
It was reported that a part of the tip of a biopsy forceps broke off in the patient during a procedure.
Patient Sequence No: 1, Text Type: D, B5
[10257580]
The user facility reported that a portion of the tip of the device broke off inside the patient during the procedure. There was no report of patient injury or any adverse health issues due to this event. Sterilmed will continue to monitor this situation and keep fda apprised of any updates related to the condition of the patient in the future. Sterilmed conducted an internal investigation on the device in question and the tip of the device was confirmed to broken. The mechanism that controls the actuation of the jaws was compromised due to the breakage of an eyelet that supports this mechanism. No root cause for this failure has been identified, but it was confirmed through device records that the device was not sent to the user facility in the damaged condition. It is noted that the occurrence of this type of failure is extremely remote and in no way related to the fact that the device was a reprocessed device. One hundred percent of biopsy forceps, like all sterilmed reprocessed devices, undergo full inspection prior to shipment to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2010-00015 |
| MDR Report Key | 2805410 |
| Report Source | 06 |
| Date Received | 2010-11-23 |
| Date of Report | 2010-11-23 |
| Date of Event | 2010-10-27 |
| Date Mfgr Received | 2010-10-27 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2012-10-31 |
| 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. NORTH |
| 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 COLD BIOPSY FORCEPS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | NON |
| Date Received | 2010-11-23 |
| Returned To Mfg | 2010-11-04 |
| Model Number | 1599 |
| Device Expiration Date | 2010-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2010-11-23 |