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

Model Number 173030

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: FORCEPS, OBSTETRICAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8327351
• MDR Text Key: 135875392
• Report Number: 2647580-2019-00781
• Device Sequence Number: 1
• Product Code: HDA
• UDI-Device Identifier: 10884523000757
• UDI-Public: 10884523000757
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1