MAUDE Adverse Event Report: STERILMED, INC. MULTI CLIP APPLIER LIGACLIP ERCA ROTATING 20 LARGE CLIPS; CLIP, IMPLANTABLE, REPROCESSED

Catalog Number	ETHER420
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) was reviewed and there are no observed discrepancies upon review of the device history record.An event date of (b)(6) 2018 was provided with the exact date unknown.Therefore, the first day of the month was used.(b)(4).
Event or Problem Description
It was reported that a (b)(6) patient underwent a laparoscopic cholecystectomy procedure with a multi clip applier ligaclip erca rotating 20 large clips and the clips became sissored.The surgeon was using the reprocessed clip applier and the clips scissored, in which the tips overlapped creating a twist.Those staples were removed, the stapler was removed from the field and a new stapler that was not processed was used to complete the procedure.There were no patient consequences.This event has been assessed as a malfunction.
Additional Manufacturer Narrative
It was reported that a 48-year-old patient underwent a laparoscopic cholecystectomy procedure with a multi clip applier ligaclip erca rotating 20 large clips and the clips became sissored.The device was returned for analysis, along with 2 of the noted misfired/retrieved clips, on january 23, 2019.There was no other additional information provided about how many clips were fired in total (if the two returned were the only clips fired is undetermined).The device was shipped to the account with at least 10 clips inside.The device was returned with a clip still loaded in the jaws.However, upon inspection the jaws were observed to be in a yielded and misaligned condition.Possible causes for the yielded condition found may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.Such a condition for the jaws may lead to malformed clips.These warnings and precautions are noted in the instructions for use for reprocessed multiple clip appliers.The device was then actuated to examine the condition of a fired clip.During the initial firing, the misalignment of the jaws could be further verified, and the twisting of the loaded clip was observed.The clip appeared ribbon-shaped.The device was actuated ten more times.The device was inconsistent in the appearance of the fired clips.Of the remaining 10 clips, 7 clips had the proper pinch and alignment, but 3 appeared ribbon-shaped.After the final clip expelled the device handle and jaws locked as would be expected.There were no noted discrepancies observed during review of the device history record, where, as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.This includes firing a clip and examining its appearance for proper pinch and alignment, as well as observing and noting the device's performance during the actuation.As the device was used and the failure occurred during its use, no conclusion as to the root cause of the reported issue could be determined.Manufacturer ref.Number: (b)(4).

• Brand Name: MULTI CLIP APPLIER LIGACLIP ERCA ROTATING 20 LARGE CLIPS
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8152843
• Report Number: 2134070-2018-00113
• Device Sequence Number: 10836804
• Product Code: NMJ
• UDI-Device Identifier: 10888551018944
• UDI-Public: 10888551018944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2019
• Device Catalogue Number: ETHER420
• Device Lot Number: 2065057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 48 YR