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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); No Apparent Adverse Event (3189)

Patient Problems Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2021.Event day and event month were not reported.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information.To date, no additional information has been received.If further details are received at a later date, a supplemental medwatch will be sent: was this bile leak controlled during the same procedure? if controlled during the same procedure, how was bile leak controlled (for example, was a new el5ml device used to complete the procedure)? was there any patient consequence? or was this a post-operative bile leak that was discovered after the procedure? if discovered after the procedure, how was the patient's bile leak treated? if post-op bile leak, what is the patient's current status or condition? 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 or additional information is received at a later date, the investigation will be updated as applicable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a lap cholecystectomy, it was reported there were loose clips and they had a bile leak.Clips were believed to be in good position.It is unknown how the procedure was completed.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2021.Event day and event month were not reported.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information.To date, no additional information has been received.If further details are received at a later date, a supplemental medwatch will be sent: was this bile leak controlled during the same procedure? if controlled during the same procedure, how was bile leak controlled (for example, was a new el5ml device used to complete the procedure)? was there any patient consequence? or was this a post-operative bile leak that was discovered after the procedure? if discovered after the procedure, how was the patient's bile leak treated? if post-op bile leak, what is the patient's current status or condition? 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 or additional information is received at a later date, the investigation will be updated as applicable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a lap cholecystectomy, it was reported there were loose clips and they had a bile leak.Clips were believed to be in good position.It is unknown how the procedure was completed.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Date sent: 2/18/2022.H2: additional information received: account executive spoke with doctor in person.He described the "bile leak" as intraoperative after trying to place a clip.He recognized the oozing during the procedure in question and placed a silk tie laparoscopically to stop the leak.There were no patient consequences to note.No further information to provide.H11=corrected data=h6.H6: health effect - clinical code: e2403.H6: health effect - impact code: f26.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 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: 13256541
• MDR Text Key: 285943332
• Report Number: 3005075853-2022-00289
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1