MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SEMI RIGID ALLIGATOR FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number GYA-5

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2023

Event Type  Injury  

Event Description

While using essure scope set, the grasper jaw broke off in the uterus of the patient.The provider used another forcep to remove the broken piece.There was no harm to the patient.

• Brand Name: SEMI RIGID ALLIGATOR FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH
• MDR Report Key: 17781853
• MDR Text Key: 323947698
• Report Number: MW5145925
• Device Sequence Number: 1
• Product Code: GEN
• 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: 09/15/2023

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 Catalogue Number: GYA-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ESSURE SCOPE SET.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian