MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SURGICAL LIQUID SCOPE WARMOR, SHORT VERSION (2 BUTTONS) , STERILE (10/B; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number PS-550

Device Problems Contamination (1120); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Blue warmer leaked onto sterile back table noted to leave white flaky residue on scope /scope warmer.Fda safety report id # (b)(4).

• Brand Name: SYMMETRY SURGICAL LIQUID SCOPE WARMOR, SHORT VERSION (2 BUTTONS) , STERILE (10/B
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): SYMMETRY SURGICAL INC.
• MDR Report Key: 13251769
• MDR Text Key: 283846029
• Report Number: MW5106629
• Device Sequence Number: 1
• Product Code: NWV
• 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: 01/10/2022

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: PS-550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic