MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ACUCLIP RIGHT-ANGLE CLIP APPLIER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMSA8
Medical Device Problem Codes	Unintended Ejection (1234); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional information has been requested but not yet received.A supplemental will be submitted upon receipt of any new information.
Event or Problem Description
According to the reporter: a thoracic surgery for a hyperhidrosis procedure (damp thoracic nerve to avoid excess sweating) was performed using assisted thoracoscopy surgery image.The clips ejected from the cartridge and up to one closed correctly so the procedure was finished using the device.The clips that fell into the cavity were removed through a laparoscopic needle bar.In the second visit post-surgery, it was detected that the pathology still persisted.An x-ray was preformed because the excessive sweating still persisted post-op.The x-ray confirmed that the clips did not close correctly.A re-intervention is being planned to solve patient pathology.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received from the account stated that the clips jumped / ejected when being placed on the thoracic nerve.They had to try 3 to 4 times until it remained fixed.The issue is that the patient seemed not to maintain sufficient pressure on the nerve, so when it came for the checking visit, the palmar sweating still persisted.There is no date scheduled for the reoperation.
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of one sealed device.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.There were no visual or functional abnormalities noted during pmv testing.The clips were fired on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and returned to the open position and each remaining clip loaded properly in the jaw.A review of the device history record indicates this device lot number was released meeting all quality specification at the time of manufacture.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: ACUCLIP RIGHT-ANGLE CLIP APPLIER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• MDR Report Key: 5447454
• Report Number: 2647580-2016-00073
• Device Sequence Number: 246318
• Product Code: GCJ
• UDI-Device Identifier: 20884521057514
• UDI-Public: 20884521057514
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K920599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: OMSA8
• Device Catalogue Number: OMSA8
• Device Lot Number: P5B0372CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/19/2016
• Supplement Report FDA Received Date: 03/04/2016; 03/28/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention