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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
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 a laparoscopic myomectomy procedure, while grasping the uterine myoma, the device suddenly broke from the top of the head.A new device was used to complete the case.There was no 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.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product 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: 8327351
• Report Number: 2647580-2019-00781
• Device Sequence Number: 13487718
• Product Code: HDA
• UDI-Device Identifier: 10884523000757
• UDI-Public: 10884523000757
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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 Expiration Date: 03/31/2023
• Device Model Number: 173030
• Device Catalogue Number: 173030
• Device Lot Number: P8C1345PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1