MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. CLICKLINE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 30310ODG

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Mechanical Jam (2983)

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

Event Date 03/22/2018

Event Type  malfunction  

Event Description

The jaw was jammed open so the instrument was removed from the patient and put on the back table.The scrub tech tried to force it closed and kept pulling on it.It suddenly closed but the jaw was obviously "floppy".On closer inspection they noticed that the screw was missing.I have attached a picture of the one missing the screw and one with a screw intact.

• Brand Name: CLICKLINE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave # 100; el segundo CA 90245
• MDR Report Key: 7537206
• MDR Text Key: 109097272
• Report Number: 7537206
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2018,04/17/2018

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: Other
• Device Model Number: 30310ODG
• Device Catalogue Number: 30310ODG
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2018
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR