MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-06-22 for STERNAL CRIMPER 342004 manufactured by Teleflex Medical.
[17632423]
Alleged event: the crimper does not open completely which inhibits the clips from being used to secure the sternum. Found during product demonstration. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[17834478]
Qn#(b)(4). The device sample has been returned to the manufacturer however the investigation report has not been submitted at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[23951459]
(b)(4). Device history record (dhr) review was conducted and the noted complaint resulted in a change of supplier and increased inspection requirements in august of 2009. (2) samples of 342004 lot xx8 (dec 2008) were received for the same issue. Both samples will be investigated together. No visual concerns were noted. The devices were functionally evaluated to observe the leaf spring rubbing on the attachment screw. This friction prevents free movement of the jaws to return to a fully open position. The jaws may still be used with a light pulling force on the handles. The device is still functional as-is. No further investigation is required. This issue was previously investigated and corrected in august of 2009. A previous incident resulted in a change of supplier and increased inspection requirements. There have been no instances since the corrective action was implemented. The customer will be issued replacements.
Patient Sequence No: 1, Text Type: N, H10
[23951460]
Alleged event: the crimper does not open completely which inhibits the clips from being used to secure the sternum. Found during product demonstration. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2015-00214 |
| MDR Report Key | 4859486 |
| Report Source | 05,06,07 |
| Date Received | 2015-06-22 |
| Date of Report | 2015-05-28 |
| Date of Event | 2015-05-15 |
| Date Mfgr Received | 2015-07-22 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERNAL CRIMPER |
| Product Code | HBP |
| Date Received | 2015-06-22 |
| Returned To Mfg | 2015-06-10 |
| Catalog Number | 342004 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-22 |