MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) CANNULA, COHEN, W/ TWO ACORNS; CANNULA OR ACORN

Device Problems Misconnection (1399); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A full investigation could not be completed as the actual device was not returned to the richard wolf facility as of 10/05/2015.Intrauterine probe set consists three items: intrauterine probe (id #8378.00) small cannula/acorn (id #8378.90) large cannula/acorn (id #8378.91) reporting facility has been contacted twice for additional information as well as actual device or photos be submitted for investigation, no response as of 10/05/2015.Due to no response, device id and lot # is unknown.An acorn (small or large) is screwed on to the end of a probe prior to use.Sometime during the case acorn unscrewed from end of probe and remained in patient at end of case.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.The ifu instructs the user to "immediately before and after each use, check the products for damage, loose parts and completeness." trending showed there has been (b)(4) similar incidents in the last five years.(mdr1418479-2011-0020 & mdr1418479-2013-00013) reporting facility has purchased 21 intrauterine probe sets in the last 10 years (last purchase (b)(6) 2012).Individual purchased listed below: no intrauterine probes (id #8378.00) in last 10 years.Five small cannula/acorn (id #8378.90) in last 10 years (last purchase (b)(6) 2012).No large cannula/acorn (id #8378.91) in last 10 years.(b)(4) considers this matter closed.However, in the event we receive any devices for investigation or any additional information is received, (b)(4) will provide fda with follow-up information.Device not returned for evaluation.

Event Description

Facility contacted richard wolf medical (b)(4) and reported sometime during a case, an acorn unscrewed from the end of a probe and remained in patient.After case was completed, patient went to restroom where foreign object was expelled.No injury to patient reported.

• Brand Name: CANNULA, COHEN, W/ TWO ACORNS
• Type of Device: CANNULA OR ACORN
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 5128774
• MDR Text Key: 27859572
• Report Number: 1418479-2015-00033
• Device Sequence Number: 1
• Product Code: LKF
• 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
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1