MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-04-08 for CIRCON ACMI TIMBERLAKE OBTURATOR ETOR-24 manufactured by Circon Acmi.
[99853]
Pin securing obturator tip was allegedly protruding and caused laceration of pt's urethra.
Patient Sequence No: 1, Text Type: D, B5
[7782329]
Problem likely occurred due to a processing problem subsequently corrected; and was exacerbated by ultrasonic cleaning by the customer, contrary to product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-1998-00017 |
| MDR Report Key | 162402 |
| Report Source | 06 |
| Date Received | 1998-04-08 |
| Date of Event | 1998-03-09 |
| Date Mfgr Received | 1998-03-13 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1998-04-16 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCON ACMI TIMBERLAKE OBTURATOR |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 1998-04-08 |
| Returned To Mfg | 1998-03-13 |
| Model Number | ETOR-24 |
| Catalog Number | ETOR-24 |
| Lot Number | AZ (1/96) |
| 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 | 153593 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST STAMFORD CT 069041971 US |
| Baseline Brand Name | TIMBERLAKE OBTURATOR |
| Baseline Generic Name | OBTURATOR |
| Baseline Model No | ETOR-24 |
| Baseline Catalog No | ETOR-24 |
| Baseline ID | NA |
| Baseline Device Family | OBTURATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-04-08 |