MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-07-19 for Z-CLAMP Z160077GY * manufactured by Coopersurgical, Inc..
[472489]
During a total abdominal hysterectomy, the clamp broke and the broken piece fell into the patient. The broken piece was retrieved manually fingrs or forceps. )
Patient Sequence No: 1, Text Type: D, B5
[7790868]
There was some evidence of slight blood rust that may have been a small contributing factor in the breakage. The most likely caused of the breakage was excessive force applied to the device during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2005-00019 |
| MDR Report Key | 735974 |
| Report Source | 06 |
| Date Received | 2005-07-19 |
| Date of Report | 2005-07-19 |
| Date of Event | 2005-07-05 |
| Date Mfgr Received | 2005-07-05 |
| Date Added to Maude | 2006-07-19 |
| 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 | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUBULL 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 | Z-CLAMP |
| Generic Name | NON-SLIPPING ATRAUMATIC HYSTERECTOMY FORCEPS |
| Product Code | HCZ |
| Date Received | 2005-07-19 |
| Model Number | Z160077GY |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 723864 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | * TRUMBULL CT * US |
| Baseline Brand Name | Z-CLAMP |
| Baseline Generic Name | NON-SLIPPING ATRAUMATIC HYSTERECTOMY FORCEPS |
| Baseline Model No | Z160077GY |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-07-19 |