MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.; HEMOSTAT

Catalog Number 32-4001

Device Problem Break (1069)

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

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

During surgery, mosquito hemostat in use tip of one side broke.

• Type of Device: HEMOSTAT
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 5083586
• MDR Text Key: 26009185
• Report Number: 5083586
• Device Sequence Number: 1
• Product Code: EMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 32-4001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR