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	Bent (1059); Entrapment of Device (1212)
Health Effect - Clinical Codes	Tissue Damage (2104); Perforation of Vessels (2135)
Date of Event	06/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) (b)(6).(b)(4).
Event or Problem Description
According to the reporter: during a living donor kidney transplant procedure, the devices were being applied to the renal artery.The first device fired one clip okay and then the device misfired on the second clip.The second device fired two clips okay and would not release from the artery on the third clip.Had to pull the device off which caused a tear in the tissue.The surgeon was frustrated and bent the third device.The procedure was completed with a straight clip applier.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of three right-angle multiple clip appliers opened by the account and two right-angle multiple clip appliers which were still in packaging.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, engineering review of the product, and an evaluation of the returned device.The reported condition for this incident states that the instruments locked on tissue, clips did not load properly and shafts bent.Instrument one was partially applied with eighteen clips remaining in the channel.The shaft was bent.The shrink wrap was damaged at the bend and the distal end near the jaw.The jaw was damaged.The condition of this device precluded evaluation.Based on the evaluation it was determined that the bent shaft of the instrument one was caused during clinical application.Replication of the bent shaft condition may occur with intentional over flexure of the shaft during clinical application causing the shaft to bend.Visual inspections of the remaining instruments revealed no abnormalities.Instruments two, three and four were functionally tested and found to operate as expected.Instrument five was fired on test media and the handle was found to hesitate.This condition was determined to have occurred as the result of a manufacturing error.A process enhancement has been initiated to prevent this condition from recurring.A review of the device history record indicates this device lot number was released meeting all quality specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation 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: 5738403
• Report Number: 2647580-2016-00337
• Device Sequence Number: 10110
• Product Code: GCJ
• UDI-Device Identifier: 10884521057517
• UDI-Public: (01)10884521057517(17)200930(10)P5J0283X
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K920599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2016

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: 09/30/2020
• Device Model Number: OMSA8
• Device Catalogue Number: OMSA8
• Device Lot Number: P5J0283X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/21/2016
• Supplement Report FDA Received Date: 07/13/2016; 11/10/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR