MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-29 for RIGID 3-PRONG GRASPER FOR RETRIEVAL OF STONES RPG-437 manufactured by Gyrus Acmi, Inc..
[1359715]
During a procedure to remove a kidney stone fragment through the scope, the entire end of the 3 prong grasping forceps broke off in the kidney. The piece was retrieved from the pt using another grasper with no pt harm.
Patient Sequence No: 1, Text Type: D, B5
[8792684]
The device is not being returned to gyrus acmi. It is being sent to a third party repair facility, sms, for eval. As a result, a determination can not be made at this time. If further info becomes available from the repair facility, gyrus acmi will update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2010-00019 |
| MDR Report Key | 1785684 |
| Report Source | 06 |
| Date Received | 2010-07-29 |
| Date of Report | 2010-07-29 |
| Date of Event | 2010-06-14 |
| Date Facility Aware | 2010-06-14 |
| Date Mfgr Received | 2010-07-13 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2011-01-31 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 93 NORTH PLEASANT ST |
| Manufacturer City | NORWALK OH 44857 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIGID 3-PRONG GRASPER FOR RETRIEVAL OF STONES |
| Generic Name | RIGID 3-PRONG GRASPING FORCEPS |
| Product Code | JEK |
| Date Received | 2010-07-29 |
| Model Number | RPG-437 |
| Catalog Number | RPG-437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST NORWALK OH 44857 US 44857 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-29 |