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

Model Number 173052

Device Problem Mechanical Jam (2983)

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

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, the surgeon cannot use the device at the beginning due to the device being jammed.The device was removed and another same device was used.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No damage was noted to the e piece.During firing, the tacks seated properly, but handle did not retract after firing.The leaf spring was loose on handle.The unit was opened as instructed by engineering and it was noted the leaf spring was detached and rolled.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.Root cause of the reported condition is due to an excessive amount of adhesive being applied to the spring retainer during the assembly process.A process improvement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

According to the reporter, while intending to close the mesenteric window during a laparoscopic gastric bypass, the surgeon had placed the stapler¿s distal end onto the mesentery and the staple became jammed in the device and the stapler was no longer usable.The staple did not penetrate the patient tissue nor was it released from the stapling device.The device was removed and another same device was used without any issue.There was no patient injury.

Manufacturer Narrative

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: 7570473
• MDR Text Key: 110166786
• Report Number: 2647580-2018-02730
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070523
• UDI-Public: 10884521070523
• 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,Followup,Followup
• Report Date: 10/03/2018

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 Expiration Date: 12/31/2022
• Device Model Number: 173052
• Device Catalogue Number: 173052
• Device Lot Number: P7M1036X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/06/2018; 07/09/2018; 08/08/2018
• Supplement Dates FDA Received: 06/21/2018; 07/31/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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
• Patient Age: 49 YR