MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) MONOPOLAR HOOK ELECTRODE

Model Number	8384.423
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf medical instruments (rwmic) received actual device from user facility on 06/19/2017.A visual inspection of device found "hook" missing and insulation near tip damaged by laser.In addition third party repair (non rwmic) performed on electric plug of device.User facility contacted in an effort to gather additional/missing information, no response as of 06/23/2017.No similar events resulting in an mdr have occurred on this device in the last three years.Manufacturer date: 11/2004 (12 years old) rwmic service dates: n/a.Tip or hook of device was never found, it may or may not be in patient."hook" is made of stainless steel, specifically en type 1.4301 which is comparable to us aisi type 304 stainless steel.Rwmic considers this matter closed.However, in the event rwmic receives additional information, a follow-up report will be provided to fda.
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) was notified by facility that during a procedure the tip of the device in question went missing after surgeon pulled the device from the trocar.A search was performed with a fluoroscopy it could not be confirmed tip was left in patient, tip was never found.No injury to the patient was reported.
Additional Manufacturer Narrative
Additional information was received from facility on 07/13/2017.

• Brand Name: MONOPOLAR HOOK ELECTRODE
• Common Device Name: MONOPOLAR HOOK ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 6664057
• Report Number: 1418479-2017-00013
• Device Sequence Number: 57166
• Product Code: GEI
• UDI-Device Identifier: 04055207015278
• UDI-Public: 04055207015278
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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
• Operator of Device: Physician
• Device Model Number: 8384.423
• Device Catalogue Number: 8384.423
• Device Lot Number: 256N04P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 92