MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. KLEPPINGER; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Model Number 72-9704005714

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Event Description

Kleppinger instrument "will not work" per reporting staff.We are continuously sending them out for repair.The device in question is out for repair.No harm.Event reached patient, but no harm was evident.Name of operation: hysteroscopy with dilatation and curettage.Laparoscopy with co2 laser vaporization of endometriosis and myomectomy.Fda safety report id# (b)(4).

• Brand Name: KLEPPINGER
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• MDR Report Key: 9859882
• MDR Text Key: 184482910
• Report Number: MW5093859
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72-9704005714
• Device Lot Number: E10894S10
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 91