MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-16 for PRECISOR PULMONARY BIOPSY FORCEP 100513 manufactured by Conmed Endoscopic Technologies.
[485856]
One day after obtaining a tissue sample from the duodenum, the pt vomited after each feeding. An endoscopic procedure was performed and found that a hematoma had had formed in the area of the first sample site. It appeared as if the tissue had been torn which may have been a result of the jaws not being sharp enough or aligned correctly to cut thereby tearing the tissue instead of cutting it. It is unk how many samples were taken with the device. The pt's hospital stay was extended while they received iv nutrition. The pt was discharged three days after the procedure as the pt's mother was nurse and was able to continue administering the iv nutrition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1223688-2006-00012 |
| MDR Report Key | 715769 |
| Report Source | 06 |
| Date Received | 2006-05-16 |
| Date of Report | 2006-04-18 |
| Date of Event | 2006-03-01 |
| Date Mfgr Received | 2006-04-18 |
| Date Added to Maude | 2006-05-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEBRA LEVASSEUR |
| Manufacturer Street | 129 CONCORD ROAD, BLDG 3 |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9789644241 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TEMUALIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISOR PULMONARY BIOPSY FORCEP |
| Generic Name | FORCEP |
| Product Code | DWZ |
| Date Received | 2006-05-16 |
| Model Number | NA |
| Catalog Number | 100513 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 704840 |
| Manufacturer | CONMED ENDOSCOPIC TECHNOLOGIES |
| Manufacturer Address | * BILLERICA MA 01821 US |
| Baseline Brand Name | PRECISOR PULMONARY BIOPSY FORCEP |
| Baseline Generic Name | FORCEP |
| Baseline Model No | NA |
| Baseline Catalog No | 100513 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-05-16 |