MAUDE Adverse Event Report: DEBAKEY FORCEPS (INSULATED)/DEBAKEY FORCEPS; FORCEPS, GENERAL PLASTIC

Catalog Number ASST-AG 9733026

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Purchased debakey vase 8" insulated forcep and debakey 2.8 mm forcep.Prior to use tested for any compromises testing results - positive.Never used on pt.(b)(6).

• Brand Name: DEBAKEY FORCEPS (INSULATED)/DEBAKEY FORCEPS
• Type of Device: FORCEPS, GENERAL PLASTIC
• MDR Report Key: 7965103
• MDR Text Key: 123941092
• Report Number: MW5080558
• Device Sequence Number: 2
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ASST-AG 9733026
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1