MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for DUROTIP DISSECTING SCISSORS BC559R manufactured by Aesculap.
[95743443]
A (b)(6) female patient underwent left total hip replacement. During procedure, it was noted that two pieces of the long mayo scissors had broken off. Diagnostic imaging was utilized to successfully retrieve both pieces. Rest of procedure concluded uneventfully and patient was subsequently discharged home.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5074175 |
MDR Report Key | 7142072 |
Date Received | 2017-12-21 |
Date of Report | 2017-12-20 |
Date of Event | 2017-12-04 |
Date Added to Maude | 2017-12-22 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | DUROTIP DISSECTING SCISSORS |
Generic Name | DUROTIP DISSECTING SCISSORS |
Product Code | HRR |
Date Received | 2017-12-21 |
Catalog Number | BC559R |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | AESCULAP |
Manufacturer Address | CENTER VALLEY PA 18034 US 18034 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-12-21 |