MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. CUTTING ELECTRODE

Model Number 8416.0305

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The user facility will be contacted again to obtain additional information.A follow up report will be submitted upon receipt of additional information.Rwmic considers this case open.

Event Description

On april 26, 2019, richard wolf medical instruments corporation (rwmic) received the following information: customer received wrong product.Box was labeled as loop electrodes (part # 8416.0305), but instead contained hook electrodes.A total of five electrodes in the box were hooks instead of loops.On august 29, 2019, rwmic received the following additional information: was the issue identified during a procedure? yes.Was there any patient involvement? no patient harm, but delayed case while correct supply was obtained from the main hospital.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was the scheduled procedure completed? yes, by using product from the main hospital, couriered over to the (b)(6) (about 20 minutes away).

• Brand Name: CUTTING ELECTRODE
• Type of Device: CUTTING ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: daisy ramos ; 353 corporate woods parkway; vernon hills, IL 60061-3110 ; 8479131113
• MDR Report Key: 9090336
• MDR Text Key: 219234033
• Report Number: 1418479-2019-00050
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/29/2019

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: No Information
• Device Model Number: 8416.0305
• Device Catalogue Number: 8416.0305
• Device Lot Number: 1390827
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other