MAUDE Adverse Event Report: 3M COMPANY 3M¿; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 9130

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Opened the device when the patient was in the room; not used on the patient yet.Noticed missing back part at end of cord (white plastic).

• Brand Name: 3M¿
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 14117423
• MDR Text Key: 289338356
• Report Number: 14117423
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9130
• Device Catalogue Number: 9130
• Device Lot Number: 202409LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White