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

Model Number LT300

Device Problems Use of Device Problem (1670); Failure to Form Staple (2579); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported that during a laparoscopy procedure, during the clipping of the cystic artery, the clips bent and did not perform adequate hemostasis.Additionally, the clips were released once they were placed on the clipping site, which caused difficulty when performing the procedure, without granting safety of hemostasis, it was determined the user was not using the lt300 titanium clips with the correct clip applier.That means they were not using the ethicon clip applier, they were using another or wrong clip applier from another commercial company, so they were not carrying out a correct clip closing process.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product is received at a later date, the investigation will be updated as applicable.Attempts were being made to obtain additional information.To date, no additional information has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent: please provide more details, was there any issue with bleeding? if yes, what was the amount of the blood loss (mls)? was a transfusion required? was the procedure altered as a result of the event? what is the current patient status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13668677
• MDR Text Key: 286752650
• Report Number: 3005075853-2022-01345
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: 10705036012825
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: LT300
• Device Catalogue Number: LT300
• Device Lot Number: P4T739
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1