MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173054

Device Problems Failure to Fire (2610); Human-Device Interface Problem (2949); Mechanical Jam (2983)

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

Event Date 07/27/2018

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 laparoscopic inguinal hernia repair, the device was not firing staples and the cartridge jammed and would not move.No staples were fired from the device as the handle would not move.They tried to remove the load and replace it but could not get the load out of the device.The device did not 'cut' the tissue but rather fires single staples.Another device was opened and used without incident.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The e-piece was partially disengaged from the device on one side.There was evidence of weld on the device.The instrument was applied to the appropriate test media.The remaining tacks deployed improperly and did not seat properly due to the disengaged e piece.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of excessive manipulation of the device.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 UNIVERSAL 65
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 7788777
• MDR Text Key: 117287845
• Report Number: 2647580-2018-04090
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070530
• UDI-Public: 10884521070530
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2018

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
• Device Operator: Health Professional
• Device Model Number: 173054
• Device Catalogue Number: 173054
• Device Lot Number: P7H1792X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 12/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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