MAUDE Adverse Event Report: SMITH AND NEPHEW AMBIENT SUPER MULTIVAC 50 3.75MM 50 DEGREE SUCTION IFS; COAGULATION DEVICE

Catalog Number ASHA4830-01

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2018

Event Type  malfunction  

Event Description

During shoulder arthroscopy case when the instrument was removed from pt after use, the surgeon noticed the tip of the instrument was missing.Staff were unable to locate the missing tip, a closing x-ray was taken with inconclusive results.The surgeon returned to the operating room, found and retrieved the tip from the pt arthroscopically.

• Brand Name: AMBIENT SUPER MULTIVAC 50 3.75MM 50 DEGREE SUCTION IFS
• Type of Device: COAGULATION DEVICE
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 7323100
• MDR Text Key: 101995064
• Report Number: MW5075742
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2020
• Device Catalogue Number: ASHA4830-01
• Device Lot Number: 2006076
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 105