MAUDE Adverse Event Report: ENDOPLUS FORCEPS, TENACULUM

Model Number	8370.26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse from user facility notified a (b)(4) sales representative that during a case, one of the prongs on the device broke off in patient.Portion which broke off was easily retrieved, a back up device was readily available and procedure was completed with minimal delay.No injury to patient or staff was reported.Device consists of three parts: handle, sheath, tenaculum insert.Handle is manufactured by rwmic and then sent to endoplus where they manufacture the sheath and tenaculum insert.Endoplus then combines the three parts and returns a complete device to (b)(4) for distribution.Manufacture date - aug2011.Customer purchase date - (b)(6) 2011.Request for additional/missing information has been sent to user facility, no response as of 30mar2017.Device was has not yet been received at (b)(4) as of 30mar2017.Device will be sent to endoplus for investigation if and when it is returned to (b)(4).(b)(4) considers this matter closed.However, in the event (b)(4) receives the device or any additional information, (b)(4) will provide manufacturer of the tenaculum (endoplus) with follow-up information/device.

• Brand Name: FORCEPS, TENACULUM
• Common Device Name: FORCEPS
• Manufacturer (Section D): ENDOPLUS; 750 tower road; suite a; mundelein IL 60060
• MDR Report Key: 6445896
• Report Number: 1418479-2017-00006
• Device Sequence Number: 658225
• Product Code: HET
• UDI-Device Identifier: 00814334021194
• UDI-Public: 00814334021194
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/03/2017
• Report Date (Section F): 03/30/2017

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: 8370.26
• Device Lot Number: 1U11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/30/2017