MAUDE Adverse Event Report: RICHARD WOLFF; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 8383.73

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/04/2018

Event Type  malfunction  

Event Description

When doctor went to use laparoscopic suction cannula ((b)(4)) the screw attachment on the stopcock part of the suction came off leaving the small spring in doctor's hand.The spring was caught by surgeon and did not reach the patient.

• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): RICHARD WOLFF; 353 corporate woods pkwy.; vernon hills IL 60061
• MDR Report Key: 7205578
• MDR Text Key: 97751641
• Report Number: 7205578
• Device Sequence Number: 1
• Product Code: HFG
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8383.73
• Device Catalogue Number: 8383.73
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2018
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2018
• 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
• Treatment: NO; NOT APPLICABLE.
• Patient Age: 67 YR