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

Model Number	173030
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2018
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, when grasping lobe of a lung during a laparoscopic lobectomy, the grasper fell apart.The handles were binding while clamped on tissue.The surgeon had been grasping tissue before this with no difficulty.They pulled another grasper and continued with the procedure.There was no patient injury.
Additional Manufacturer Narrative
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Handle of device had broken at pivot\attachment point.Both covers of the handles were broken.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur when the device is activated (handles contracted) with excessive force and\or used for leveraging; these actions would cause the handle lever to detach and break open the cover of the handle body.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 7969354
• Report Number: 2647580-2018-04993
• Device Sequence Number: 1488168
• Product Code: HDA
• UDI-Device Identifier: 10884523000757
• UDI-Public: 10884523000757
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 02/01/2019

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: 03/31/2022
• Device Model Number: 173030
• Device Catalogue Number: 173030
• Device Lot Number: P7H1803PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1