MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GRASP; FORCEPS, OBSTETRICAL

Model Number	173030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during sleeve gastrectomy procedure, the device was use for grasping and the tip of the device was broken in the middle of surgery.The new product was opened to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the jaw of the device was broken at the fulcrum.Pmv performed functional testing and the jaw rotated without difficulty.Other functions of device could not be tested due to condition of device.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.Replication of the broken jaw may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GRASP
• Common Device Name: FORCEPS, OBSTETRICAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8657677
• Report Number: 2647580-2019-02789
• Device Sequence Number: 2662677
• Product Code: HDA
• UDI-Device Identifier: 10884523000757
• UDI-Public: 10884523000757
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K903205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 173030
• Device Catalogue Number: 173030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1