MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2007-05-08 for EXCEL CONMED PNEUMOPERITONEUM INSUFF NEEDLE 60-6050-001 manufactured by Conmed Corp..
[629384]
It was reported that, "during a lavh, the surgeon perforated the bowel and the mesentery membrane. Both were repaired immediately during the surgical procedure. The procedure was not altered. The status of the patient was reported as, "ok".
Patient Sequence No: 1, Text Type: D, B5
[7817248]
The actual device was discarded at the hospital. A new unused device of the same lot code was returned for evaluation. The device production records were reviewed. These were found to be correct. The device was visually examined and found to be assembled correctly. It worked as stated in the product insert. The report indicated that the perforations occured because the surgeon "did not hear the click. " the product insert is included as page 3 of 3. There is no indication that the device is sold as an audible device. The insert references the surgeon "feeling a click" when inserting the needle. The returned device worked as designed to. We feel the perforation most likely occured due to an error in the surgeon's technique for judging the needle placement and the insertion depth. We consider this complaint closed and the investigation completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2007-00095 |
| MDR Report Key | 846195 |
| Report Source | 01,07,08 |
| Date Received | 2007-05-08 |
| Date of Report | 2007-05-08 |
| Date of Event | 2007-03-23 |
| Date Mfgr Received | 2007-04-10 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2007-05-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CRISINO, MANAGER |
| Manufacturer Street | 252 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243078 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXCEL CONMED PNEUMOPERITONEUM INSUFF NEEDLE |
| Generic Name | DISPOSABLE INSUFFLATION NEEDLE |
| Product Code | FHO |
| Date Received | 2007-05-08 |
| Returned To Mfg | 2007-04-23 |
| Model Number | NA |
| Catalog Number | 60-6050-001 |
| Lot Number | 0603271 |
| ID Number | NA |
| Device Expiration Date | 2009-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 833289 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | * UTICA NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-08 |