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

Model Number	ETHER320
Medical Device Problem Codes	Failure to Form Staple (2579); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.The root cause of the event could not be determined based on the available information, however clinical and procedural factors including vessel or tissue characteristics, or operator technique are factors that could have contributed.Furthermore, the event could be related to the device potentially as a result of clip mis-formation or a feeding issue.As per the instructions for use, the reprocessed multiple clip applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.The tissue being ligated should be consistent with the size of the clip.The sterilmed reprocessed multiple clip applier is an automatic ligating clip applier that delivers titanium ligating clips.The instrument and clips are designed to offer a fast, efficient means of ligation.The clips are applied to the vessel or other tubular structures by positioning the jaws with the clip around the vessel and fully squeezing the handles of the applier.When the handles are completely released, a new clip is automatically advanced into the jaws of the instrument.Reprocessed multiple clip appliers have been cleaned, evaluated for continued integrity, packaged, and sterilized for a single subsequent use.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient of an unknown age and ethnicity underwent a total laparoscopic hysterectomy (tlh) with bilateral salpingo-oophorectomy (bso) using the reprocessed multi clip applier ligaclip erca rotating medium with large clips (ether320/unknown lot #) and towards the end of the procedure a clip fell off the tissue.The bleeding initially was stopped with the clip however towards the end of the case after looking back at the iliac vein, it was observed that the clip has fallen off the tissue and later found in the patient¿s abdomen not clipped to anything.No further information was provided at this time.Based on the information provided, the event of bleeding was caused as the clip did not hold and fell off the tissue.Clip not holding during the procedure is a reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient of an unknown age and ethnicity underwent a total laparoscopic hysterectomy (tlh) with bilateral salpingo-oophorectomy (bso) using the reprocessed multi clip applier ligaclip erca rotating medium with large clips (ether320/unknown lot #) and towards the end of the procedure a clip fell off the tissue.The device was not returned for evaluation; therefore, the visual and functional inspections could not be performed, and the reported issue could not be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 12010893
• Report Number: 2134070-2021-00010
• Device Sequence Number: 3425945
• Product Code: NMJ
• UDI-Device Identifier: 10888551018937
• UDI-Public: 10888551018937
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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 Model Number: ETHER320
• Device Catalogue Number: ETHER320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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