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

Model Number 174006

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photographs noted the shaft of the instrument was detached from the device.Additionally, it was noted in one of the photographs it appeared the timing was disengaged.No tacks were noted in the photograph.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported condition.No enhancements or improvements were generated for the reported condition.Additionally, the investigation detected a secondary condition of disengaged timing and disassembled device that has no relationship to the reported condition.Replication of the disengaged timing condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.Replication of the disassembled device condition may occur if the instrument is handled roughly during use.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during a laparoscopic incisional hernia repair when fixing the mesh, 28 tacks were placed in the patient body, it was found that 2 tacks were missing from the device.The customer has disassembled the device in the presence of the sales rep, but didn't found any tacks remaining, the product problem lead to an extended operation time of 30 minutes or more.An x-ray was taken next to the operating table and the ct scan of the abdomen was performed the next day but the tacks were not found.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph and one device.A visual and photographic inspection noted the shaft of the instrument was detached from the device.No tacks were received with the instrument.A functional evaluation was precluded due to the observed condition of the instrument.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Additionally, the investigation detected an unreported condition of disassembled device that has no relationship to the reported condition.Replication of this condition may occur if the instrument is handled roughly during use.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: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9125937
• MDR Text Key: 160250674
• Report Number: 2647580-2019-04804
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070407
• UDI-Public: 20884521070407
• Combination Product (y/n): N
• PMA/PMN Number: K090470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P7H1811X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 88