MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-01-14 for CONMED DISPOSABLE INSUFFLATION NEEDLE 60-6050-001 manufactured by Conmed Corp..
[375195]
It was reported that "during a laparoscopy cholerchystectomy it was noted that the needle was separated in two parts due to non proper adhesion in the join of the metallic needle with the plastic connector. "
Patient Sequence No: 1, Text Type: D, B5
[19939171]
The quality engineer confirmed the complaint. The returned device was examined under magnification. It was noted that the appropriate adhesive was present in the appropriate locaion. The device was also cross sectioned and the dimensions were within specification. We do not know why the adhesive failed to hold. Without a lot code we are do not know the mfr date of the devie, so we are unable to do a dhr review. The product complaint detabase had been searched and there are no other reports of similar events. We feel this was a very unusual event. We consider this investigation complete and the complaint closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317214-2004-00084 |
| MDR Report Key | 568052 |
| Report Source | 06,07 |
| Date Received | 2005-01-14 |
| Date of Report | 2004-12-16 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2004-12-16 |
| Date Added to Maude | 2005-01-28 |
| 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 | SHARON RUSZALA |
| Manufacturer Street | 525 FRENCH RD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243076 |
| Manufacturer G1 | CONMED CORP |
| Manufacturer Street | 310 BROAD ST |
| Manufacturer City | UTICA NY 13501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED DISPOSABLE INSUFFLATION NEEDLE |
| Generic Name | DISPOSABLE INSUFFLATION NEEDLE |
| Product Code | FHO |
| Date Received | 2005-01-14 |
| Model Number | NA |
| Catalog Number | 60-6050-001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 557880 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 310 BROAD ST. UTICA NY 13501 US |
| Baseline Brand Name | CONMED DISPOSABLE INSUFFLATION NEEDLE |
| Baseline Generic Name | DISPOSABLE INSUFFLATION NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 60-6050-001 |
| Baseline ID | NA |
| Baseline Device Family | INSUFFLATION SYSTEMS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K930474 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-14 |