MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-12-09 for MAYO COMMON DUCT PROBE SU10910018 manufactured by Allegiance Healthcare Corp..
[19959622]
Instrument cracked in half during cholecystectomy surgery. The probe cracked at one of the identification lines. The physician had the probe in his hand to position it when the breakage occurred. The instrument was not in the pt's body; therefore, no pt injury occurred as a result of the breakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1998-00358 |
| MDR Report Key | 200995 |
| Report Source | 06 |
| Date Received | 1998-12-09 |
| Date of Report | 1998-12-09 |
| Date Mfgr Received | 1998-11-11 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 1998-12-11 |
| 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 | MAYO COMMON DUCT PROBE |
| Generic Name | INSTRUMENT |
| Product Code | FGM |
| Date Received | 1998-12-09 |
| Returned To Mfg | 1998-12-04 |
| Model Number | SU10910018 |
| Catalog Number | SU10910018 |
| Lot Number | V |
| 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 | 195241 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | MAYO COMMON DUCT PROBE |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | SU10910018 |
| Baseline Catalog No | SU10910018 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-09 |