MAUDE Adverse Event Report: RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CM; SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Model Number RWG-337R

Patient Problem Insufficient Information (4580)

Event Date 05/02/2023

Event Type  Injury  

Event Description

Rwg-337r broke inside patient during percutaneous nephrolithotomy.Pin that holds the jaws in place is missing.Olympus.

• Brand Name: RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CM
• Type of Device: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• MDR Report Key: 17498521
• MDR Text Key: 320896821
• Report Number: MW5122863
• Device Sequence Number: 1
• Product Code: KOA
• 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: 08/04/2023

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: RWG-337R
• Device Lot Number: JF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White