MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-27 for SURE GRIP TISSUE GRASPER 3645-02 manufactured by G. Hipp And Sohn.
[4517723]
Spike of sure grip soft tissue grasper fell off during the second use. The spike was sequestered. No injuries were sustained by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833053-2014-00002 |
| MDR Report Key | 3919014 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-06-10 |
| Report Date | 2014-06-26 |
| Date Reported to FDA | 2014-06-26 |
| Date Reported to Mfgr | 2014-06-26 |
| Date Added to Maude | 2014-07-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 103 ESTUS DR. |
| Manufacturer City | SAVANNAH GA 31404 |
| Manufacturer Country | US |
| Manufacturer Postal | 31404 |
| Manufacturer G1 | INNOMED CORP. |
| Manufacturer Street | 103 ESTUS DR. |
| Manufacturer City | SAVANNAH GA 31404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 31404 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURE GRIP TISSUE GRASPER |
| Generic Name | RONGUER/GRASPER |
| Product Code | HXT |
| Date Received | 2014-06-27 |
| Returned To Mfg | 2014-06-23 |
| Model Number | 3645-02 |
| Catalog Number | 3645-02 |
| Lot Number | 0512GH |
| ID Number | 00840277105943 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 29 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | G. HIPP AND SOHN |
| Manufacturer Address | NEUHAUSEN OB ECK GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |