MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-11-06 for MICRODIGITAL IP 4.1 CAMERA HEAD MV-10000 manufactured by Circon Video.
[200021]
At the start of a laparoscopic tubal ligation, after the initial entry into the umbilicus, the camera fogged. Anti-fog was used on the laparoscope, but that did not adequately clear the view. After entry into the abdomen was made with a second instrument, the abdominal pressure was being lost. All instruments were removed from the abdomen until adequate abdominal pressure could be obtained, then the instruments were reinserted into the abdomen. It was then discovered that the small bowel was perforated. At that time, the view with the camera was still fogged. An open laparotomy was performed to repair the small bowel, and the pt remained in the hosp for two days. Before being discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020483-2000-00006 |
| MDR Report Key | 304000 |
| Report Source | 05,07 |
| Date Received | 2000-11-06 |
| Date of Report | 2000-10-04 |
| Date of Event | 2000-10-02 |
| Date Mfgr Received | 2000-10-04 |
| Date Added to Maude | 2000-11-14 |
| 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 |
| Manufacturer Contact | CAROLYN DE JONGE |
| Manufacturer Street | 609 BEECHWOOD RD |
| Manufacturer City | WILLOW GROVE PA 19090 |
| Manufacturer Country | US |
| Manufacturer Postal | 19090 |
| Manufacturer Phone | 2156581655 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRODIGITAL IP 4.1 CAMERA HEAD |
| Generic Name | CAMERA HEAD |
| Product Code | FWJ |
| Date Received | 2000-11-06 |
| Model Number | NA |
| Catalog Number | MV-10000 |
| Lot Number | NA |
| 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 | 294207 |
| Manufacturer | CIRCON VIDEO |
| Manufacturer Address | 6500 HOLLISTER AVE SANTA BARBARA CA 931173019 US |
| Baseline Brand Name | MICRODIGITAL IP 4.1 CAMERA HEAD |
| Baseline Generic Name | CAMERA HEAD |
| Baseline Catalog No | MV-10000 |
| Baseline ID | CAMERA HEAD |
| Baseline Device Family | IP 4.1 CAMERA SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-11-06 |