MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) GRASPING FORCEPS INSERT

Model Number	8393.293
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Facility called (b)(4), during a procedure, to report the device in question broke.One of the grasping jaws broke off and facility was not 100% sure all parts of device had been accounted for.Facility requested drawing of device and indicated patient was in process of being x-rayed in an effort to assure all parts were removed.No injury to patient reported.Facility has not supplied the lot # of device, therefore the manufacturer date, purchase date and service dates are unknown at this time.Facility has purchased (b)(4) similar devices (id #8393.293) since feb2014.There has been one similar incident,on this specific device (id #8393.293), in the last three years (mdr #1418479-2014-00045).Facility has been contacted twice, via email, in an effort to gather additional and missing information for this report.No response as of 09/29/2017.As of 29sep2017, device has not been returned to (b)(4).Device will be sent to manufacturer for investigation if and when it is returned to (b)(4).(b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information, (b)(4) will provide the manufacturer of device with the information.
Additional Manufacturer Narrative
Follow up #1, the following was updated/completed: patient information, product problem, suspect device, initial report, importer (device), corrected/additional data.Richard wolf medical instruments corporation (rwmic) received a medwatch (b)(4) from user facility on 11oct2017 with additional information concerning the event, which occurred on (b)(6) 2017.New information added to this follow up report.Rmic considers this matter closed.However, in the event rwmic receives any additional information a follow report will be submitted to fda.
Event or Problem Description
Follow up report #1.Procedure performed - robotic total laparoscopic hysterectomy with morcellator.X-ray performed on patient and three metallic densities were found over patients abdomen.Foreign objects were left in patients abdomen due to risk of further exploration to patients health.

• Brand Name: GRASPING FORCEPS INSERT
• Common Device Name: GRASPING FORCEPS INSERT
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6906443
• Report Number: 1418479-2017-00023
• Device Sequence Number: 745905
• Product Code: GEI
• UDI-Device Identifier: 04055207015995
• UDI-Public: 04055207015995
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017
• Report Date (Section F): 10/17/2017

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
• Operator of Device: Physician
• Device Model Number: 8393.293
• Device Catalogue Number: 8393.293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Weight: 86
• Date Report Sent to FDA: 10/17/2017