MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number LT200

Device Problems Device Slipped (1584); Failure to Form Staple (2579)

Patient Problems Pain (1994); Blood Loss (2597); No Code Available (3191)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information and the device: what is patient's current status? to date, no response has been provided and no device has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during a transoral tumor removal, ligaclips slipped from ligated vessels.Because of post-op bleeding patient needed to be operated again on (b)(6) 2019.Clip applier used with clips was karl storz germany 8665l laryngo force, another manufacturers clip applier.This clip applier was inspected prior to use for proper jaw alignment, however, the lc800 was not used to load clips.The clips were used directly from clip magazine.There were no differences in loading the clips or applying the clips.Clips were noted to be partly crossed during the initial procedure.It is unknown if the same clip applier had been used during the initial procedure and reoperation procedure.After initial procedure, patient complained of pain.It is unknown if any precipitating factors such as coughing occurred prior to occurrence of bleeding and reoperation.At reoperation, new ligaclips were placed.Patient's current status is unknown at this time.

Manufacturer Narrative

(b)(4).Pcf follow up: what is patient's current status? unknown.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9216416
• MDR Text Key: 176331103
• Report Number: 3005075853-2019-22917
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: 10705036012801
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: LT200
• Device Lot Number: R40M9D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Patient Sequence Number: 1
• Treatment: KARL STORZ GERMANY 8665L LARYNGO FORCE
• Patient Outcome(s): Required Intervention