MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-07-10 for FIXATION RING CLAMP 244001 manufactured by Rusch, Inc..
[78450]
It was stated by physician that during vasectomy procedure, the ring hook of the device broke off into patient. Procedure took 20 minutes longer and ring was removed. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1997-00065 |
| MDR Report Key | 105364 |
| Report Source | 05,06 |
| Date Received | 1997-07-10 |
| Date of Report | 1997-07-02 |
| Date of Event | 1997-06-01 |
| Date Mfgr Received | 1997-06-30 |
| Date Added to Maude | 1997-07-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXATION RING CLAMP |
| Generic Name | VASECTOMY INSTRUMENT |
| Product Code | KOA |
| Date Received | 1997-07-10 |
| Returned To Mfg | 1997-08-13 |
| Model Number | NA |
| Catalog Number | 244001 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 103610 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30036 US |
| Baseline Brand Name | VASECTOMY SCALPEL |
| Baseline Generic Name | VASECTOMY INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 244001 |
| Baseline ID | NA |
| Baseline Device Family | ANESTHESIA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K922971 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-10 |