MAUDE Adverse Event Report: STERILMED, INC. CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS; CLIP, IMPLANTABLE, REPROCESSED

Catalog Number	ETHMCL20
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for analysis.Manufacture report numbers 2134070-2019-00139 and 2134070-2019-00140 are related to the same event.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 lymphadenectomy procedure with two reprocessed clip appliers ligaclip multiple clip appliers lg clips and the device did not close properly, therefore did not clamp the vessel and increased bleeding.Both devices were replaced, and a third device completed the procedure.
Additional Manufacturer Narrative
It was reported that a 60-year-old male patient underwent a radical retropubic prostatectomy with bilateral pelvic lymphadenectomy procedure with two reprocessed clip appliers ligaclip multiple clip appliers lg clips and the device did not close properly, therefore did not clamp the vessel and increased bleeding.The devices were returned on july 24, 2019 and investigated individually.This device was visually and functionally examined upon return.There was biological contaminants observed in and around the jaw area, indicative of handling within the operative field.The device was originally sent to the account with 15 clips in the shaft.It was returned with 13 clips.There were no visual defects or damage observed; it appeared visually acceptable.The handle was actuated, and the next clip loaded into the jaw.The device was successively operated for each remaining clip and the handle mechanism locked out after the final clip fired.Each clip fired had the proper pinch and alignment expected from this device.No malfunction could be duplicated or verified.The device operated as designed.No conclusion could be determined as to the cause of the reported issue.A manufacturing record evaluation was performed for this lot and no non-conformances were identified.Manufacturer's ref.No: (b)(4).

• Brand Name: CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8754331
• Report Number: 2134070-2019-00139
• Device Sequence Number: 11244300
• Product Code: NMJ
• UDI-Device Identifier: 10888551019057
• UDI-Public: 10888551019057
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2019
• Device Catalogue Number: ETHMCL20
• Device Lot Number: 2059193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/31/2019
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 97