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

Model Number EL5ML

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t94u28.Investigation summary: the analysis results found that the el5ml device was received with no damage in the external components.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lock out after all the clips have been fired.A potential cause of the customer reported experience is the firing of all of the clips and the instrument "will not fire" (activation of the lock out mechanism).The instrument has an orange indicator that appears on the top of the handle as a reference for the user as to the quantity of clips remaining.The event described could not be confirmed as the device was returned empty.In addition, a photo was received for review.Upon visual inspection of the photo, the following was observed: the photo shows a device from jaws area and no anomalies could be observed.Based on the photo alone, the event described cannot be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

Event Description

It was reported that during a cholecystectomy, the new ligamax stuck after few firing.Surgery was delayed five minutes, but was successfully completed with a new ligamax.No fragments were generated and there were no patient consequences.No other medical intervention was required.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• 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 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9753001
• MDR Text Key: 194450598
• Report Number: 3005075853-2020-01230
• 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: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: T94U28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1