MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-01-23 for CER-VIEW F410 * manufactured by Coopersurgical, Inc..
[589884]
At completion of leep procedure, bilateral vaginal sidewall burns noted along path of sidewall retractor.
Patient Sequence No: 1, Text Type: D, B5
[7820051]
The instrument was not returned. The directions for use state the instrument should be thoroughly examined to assess the integrity of the rose coating. Any flaws such as cracks, tears or chips would disqualify the instrument for use. It is not known which type of electrosurgical generator was used nor if the proper settings for the subject electrosurgical generator were used. No conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2006-00018 |
| MDR Report Key | 820039 |
| Report Source | 06 |
| Date Received | 2007-01-23 |
| Date of Report | 2007-01-23 |
| Date of Event | 2006-08-15 |
| Date Mfgr Received | 2006-08-22 |
| Date Added to Maude | 2007-02-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CER-VIEW |
| Generic Name | LATERAL WALL RETRACTOR |
| Product Code | HDL |
| Date Received | 2007-01-23 |
| Model Number | F410 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 807514 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | * TRUMBULL CT * US |
| Baseline Brand Name | LEEP |
| Baseline Generic Name | LATERAL WALL RETRACTOR |
| Baseline Model No | F410 |
| Baseline Catalog No | F410 |
| Baseline ID | F420 |
| Baseline Device Family | CER-VIEW LATERAL WALL RETRACTOR |
| 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 | 1. Required No Informationntervention | 2007-01-23 |