MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-12-17 for 5.5MM TITANIUM INTRALINE 2 FORCE FIBER 3910-400-050 manufactured by Stryker Endoscopy Puerto Rico.
[1274196]
It was reported that "while implanting, anchor broke about halfway". The broken piece was retrieved and the rest of the anchor was left in the patient.
Patient Sequence No: 1, Text Type: D, B5
[8512560]
Additional information will be provided once investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2648666-2009-00357 |
MDR Report Key | 1579411 |
Report Source | 04 |
Date Received | 2009-12-17 |
Date of Report | 2009-11-19 |
Date of Event | 2009-11-10 |
Date Mfgr Received | 2009-11-19 |
Date Added to Maude | 2010-08-04 |
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 | UNKNOWN |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | NILA PATEL |
Manufacturer Street | 5900 OPTICAL COURT |
Manufacturer City | SAN JOSE CA 95138 |
Manufacturer Country | US |
Manufacturer Postal | 95138 |
Manufacturer Phone | 4087542000 |
Manufacturer G1 | STRYKER ENDOSCOPY PUERTO RICO |
Manufacturer Street | HIGHWAY #3, KM 130.2 LAS PALMAS INDUSTRIAL PARK |
Manufacturer City | ARROYO PR 00615 |
Manufacturer Country | US |
Manufacturer Postal Code | 00615 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 5.5MM TITANIUM INTRALINE 2 FORCE FIBER |
Generic Name | ANCHOR |
Product Code | NOV |
Date Received | 2009-12-17 |
Returned To Mfg | 2009-12-02 |
Catalog Number | 3910-400-050 |
Lot Number | 09218AE2 |
Operator | OTHER |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
Manufacturer Address | ARROYO PR 00615 US 00615 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2009-12-17 |