MAUDE Adverse Event Report: CORKSCREW INSTRUMENT

Model Number 71-5210 100221

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

(b)(6) 71-5210 100221 corkscrew instrument and it broke into 2 pieces inside patient's pelvis.Both pieces were retrieved with no complications or harm to patient.(b)(6).Fda safety report id# (b)(4).

• Brand Name: CORKSCREW INSTRUMENT
• Type of Device: CORKSCREW
• MDR Report Key: 13666933
• MDR Text Key: 286658682
• Report Number: MW5107889
• Device Sequence Number: 1
• Product Code: HWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71-5210 100221
• Device Lot Number: 71-5210 100221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White