MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) INSUFFLATOR

Model Number 2232.601

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Richard wolf medical instruments (rwmic) received actual device from user facility on (b)(6) 2018.When unit was powered up sporadic display and function occurred.A visual inspection of device found deteriorated solder joints on the power supply circuit board.Refurbished device was purchased (b)(6) 2009 and is (b)(4) years old.Device has not been serviced since being purchased.Request sent to user facility, via email, for additional/missing medwatch information, no response as of 21mar2018.No similar events resulting in a mdr has occurred on this device in the last three years.Rwmic considers this matter closed.However, in the event rwmic receives additional information, follow-up report will be submitted to fda.

Event Description

Richard wolf medical instruments corporation (rwmic) was contacted by facility and they reported the device in question (id #(b)(4)) was not working properly.Device kept shutting off during the scheduled procedure (oophorectomy) and it was decided to stop the procedure before it was completed.Date manufactured: nov2002, date purchase by facility: (b)(6) 2009 (refurbished device), date serviced: serviced 22 times between manufacturing and purchase date.Not serviced since purchase date.

Manufacturer Narrative

Rwmic requested additional information from user facility and the information in this report is the new and only information that was available.Rwmic considers this case closed.

• Brand Name: INSUFFLATOR
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 7359266
• MDR Text Key: 103161263
• Report Number: 1418479-2018-00003
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K981334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 2232.601
• Device Catalogue Number: 2232.601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2018
• Distributor Facility Aware Date: 08/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2018
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TUBING
• Patient Outcome(s): Other
• Patient Age: 35 YR