MAUDE Adverse Event Report: KLEPPINGER; COAGLATION - CUTTER, ENDOSCOPIC, BIPOLAR AND ACCESSORIES

Model Number PART # 72-970

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

Kleppinger did not work.Per instrument mgr, we have had multiple problems with the kleppingers and we constantly have to send them out for repair.This is kleppinger manufactured by millennium, part #72-970, lot# e1018; millennium.Fda safety report id# (b)(4).

• Brand Name: KLEPPINGER
• Type of Device: COAGLATION - CUTTER, ENDOSCOPIC, BIPOLAR AND ACCESSORIES
• MDR Report Key: 9793407
• MDR Text Key: 182530353
• Report Number: MW5093541
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PART # 72-970
• Device Lot Number: E1018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 70