MAUDE Adverse Event Report: STERILMED, INC. MULTIPLE CLIP APPLIER LIGACLIP; CLIP, IMPLANTABLE, REPROCESSED

Catalog Number	ETHMCM30
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old male patient underwent a radical retropubic prostatectomy with bilateral pelvic lymph node dissection procedure with a reprocessed multiple clip applier ligaclip and the clips became scissored which caused a bleeding issue.The physician tried to control bleeding with the clip applier and the reprocessed clip applier was not functioning correctly.From the start of the case, the clips would not clamp the vessels no matter how hard the surgeon would squeeze.About every third clip, they would crisscross or scissor at the tip.No matter what the surgeons would do they would not stay on the vessels.There was significant bleeding but with some additional figure-of-eight sutures hemostasis was improved.No additional, medical or surgical intervention was required.A brand-new clip applier was used to complete the procedure.
Additional Manufacturer Narrative
It was reported that a 65-year-old male patient underwent a radical retropubic prostatectomy with bilateral pelvic lymph node dissection procedure with a reprocessed multiple clip applier ligaclip and the clips became scissored which caused a bleeding issue.The returned product was received on july 24, 2019 wrapped in a plastic bag with part of its label returned.There was a cup that had 2 clips inside it.There was no note or explanation for its presence.It is implied that the clips come from the involved device.One clip appears unaligned and not fully pinched closed.The other clip appears to have been ejected fully unformed.Neither clip is scissored or ribbon-shaped.It is also observed that the device was shipped to the customer with 16 clips in the shaft.It is observed that there are 2 clips remaining in the shaft - thus it was determined that 14 clips were fired/used by the account, before this device was received for examination.It is unclear if the 2 returned clips in the cup were fired at the time the device was noted to have failed at the account.There are biological contaminants all around the distal portion of the device and inside the plastic shroud, indicative of patient contact and/or handling within the operative field.The handle is also observed to be broken and separating at the seams.The handle was loose and there was internal rattling.The handle was engaged and actuated, but there was no engagement of the jaws.The internal mechanism was broken.The shaft was observed to be bent.The bent shaft and the broken handle appear to be a result of undue force being applied to the handle, as a result of being dropped or excessive torqueing of device during use.The device will not currently operate; thus, the reported issue of failing is confirmed.The provided clips fired at the account show no indication of scissoring, and the device is incapable of firing the remaining two clips.The reported issue of scissoring clips is not confirmed.The failure mode and effects analysis notes that user error is a potential cause of failure if the "handle breaks during the procedure." the report of "not functioning correctly" is unclear, though a broken handle that no longer actuates the jaws could be the reason of the device not functioning correctly.The device history record was reviewed and a manufacturing record evaluation was performed for the finished device lot# 2058827 and no non-conformances were identified.Manufacturer's ref.No: (b)(4).

• Brand Name: MULTIPLE CLIP APPLIER LIGACLIP
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8723058
• Report Number: 2134070-2019-00137
• Device Sequence Number: 1729989
• Product Code: NMJ
• UDI-Device Identifier: 10888551019071
• UDI-Public: 10888551019071
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K033579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 10/08/2019
• Device Catalogue Number: ETHMCM30
• Device Lot Number: 2058827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR