MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-25 for MIC1333 manufactured by Sterilmed, Inc..
[73667238]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was not reviewed as no lot number was given.
Patient Sequence No: 1, Text Type: N, H10
[73667239]
It was reported that the device broke mid-procedure of a gi case while in the patient. No patient harm or consequences resulted in this. Additional details were given as follows: the jaw was retrieved and there was no damage to the patient. The wire was sticking out of the jaw.
Patient Sequence No: 1, Text Type: D, B5
[76993879]
The device was returned to the manufacturer for evaluation. During the evaluation, the drive wire with a u-joint connector was found to be bent out of its position. A review of the device history record found that the device passed all visual and functional criteria prior to being shipped to the account. As the device was used during the procedure, no definitive cause for the reported observation could be determined. Per the instructions for use, the product is to be inspected for signs of damage or sterility compromise prior to use. As the device was inserted into the colonoscope, it is assumed there was no observed damage or bent wiring prior to insertion. As noted in the instructions for use, if excessive pressure was applied during advancement into the tissue or during handle manipulation, this could? Cause jaw damage?. A bent or constricted drive wire on the device may have been caused by forceful insertion of the instrument and/or caused by over-angulation of the endoscope during the procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2017-00007 |
| MDR Report Key | 6520710 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-25 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-04-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED |
| Product Code | NON |
| Date Received | 2017-04-25 |
| Returned To Mfg | 2017-05-22 |
| Model Number | MIC1333 |
| Catalog Number | MIC1333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |