MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problems Failure to Advance (2524); Failure to Form Staple (2579); Difficult to Open or Close (2921); Mechanics Altered (2984)

Patient Problems Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unk.See attached user facility medwatch #0504240000-2020-8010.A manufacturing record evaluation was performed for the finished device lot number, p4ru56, and no non-conformances were identified.

Event Description

See attached user facility medwatch # 0504240000-2020-8010.

Manufacturer Narrative

(b)(4).Date sent: 7/27/2020.H2: additional information received: what was the specific procedure that device was used on? date of surgical procedure (b)(6) 2020 laparoscopic, converted to open distal pancreatectomy with splenectomy a 5 mm clip applier was brought into the field, used to control the pancreatic side of the vein first.The clip applier misfired resulting inadequate closure of the clip and disruption of the vein wall.Did the surgeon confirm the device jaws were through the trocar before loading the clip? unaware.Was each clip loaded and inspected to determine that a clip was in the jaws of the device prior to placing on the vessel? unaware that would be a question for the operator/surgeon.Was the device torqued or twisted when positioning device to fire on vessel? unknown how many clips were applied before the ¿misfire¿ occurred? 1.What does ¿device misfired¿ mean (please describe the specific issue that occurred with the device)? inadequate closure of the clip.Did device get stuck on tissue? yes.Did the jaws of device cut the vessel? it was the misfire of the clip.Or did a clip cut the vessel? and if so, was the clip malformed? or was the clip scissored? clip appeared to be malformed following firing.What specific vessel was the clip/device applied to? a distal vein what was the diameter of this vessel? unknown.Were there any difficulties with opening and closing the jaws? attempted to apply a new clip but would not load into the jaws of the clip applier- released the clip applier handle and tried again x one.Again, no clip was deployed into the jaws and this time the jaws failed to reopen.Could the surgeon cycle the instrument or not (what was the firing sequence)? was the convert to open due to alleged difficulties with the ethicon device or were there other technical or clinical factors that led to converting to an open procedure? it was converted to an open procedure due to the shredding of the vein and bleeding.What is the patient¿s current status? unknown.

Manufacturer Narrative

(b)(4).Date sent: 8/28/2020.H2: additional information: during the follow up process, the hospital risk management coordinator originally reported she could not send the device back to ethicon for analysis.The hospital risk management coordinator has since communicated with the ethicon risk manager and is checking with the hospital legal team to determine if they are willing to release the device.The risk management coordinator is also communicating with surgeon regarding ethicon's request for additional information regarding this reported event.To date, no email or phone contact information has been provided for the surgeon.Finally, there were also nine photos and one video clip received for review, however the photo / video review is still in progress.

Manufacturer Narrative

(b)(4).Date sent: 10/29/2020.H2: additional information: risk manager from hospital reported she had reached out to surgeon to gather additional information regarding event and received no response.In addition, nine photos and one video were received for review.Upon visual inspection of one video and nine photos, the following was observed: the photos a, c, e and video illustrate the jaws of the device and no anomalies could be observed based on these photos.The photos d and f also illustrate the jaws of the device from a side view.The tissue stop is also observed in this photo and appears to be partially separated from the jaws.The photos b, g, i, and j illustrate a malformed clip from top view.Based on the photo and video analysis, the event description reporting a malformed clip is confirmed, however no conclusion or root cause could be determined based on the limited information available.The reported issues of would not feed, would not open, and clip/jaw cutting could not be confirmed through the provided photos and video.The opportunity to perform a device analysis may provide the additional evidence necessary to identify the root cause of the reported event.,as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10329850
• MDR Text Key: 201039023
• Report Number: 3005075853-2020-03838
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention