MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA LARGE APPLIER; CLIP, IMPLANTABLE

Model Number MCL20

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 03/09/2022

Event Type  Death  

Event Description

See attached medwatch form # 5110542.

Manufacturer Narrative

(b)(4).Batch # unk.The manufacturing record evaluation is pending for the finished device lot number provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was there any difficulty with the device intraoperatively? what was the estimated blood loss? was there any difficulty with clip application? was there any clip formation issue during the surgical procedure? can you further describe the shape of the clips? is the surgeon interested in speaking with ethicon medical and engineering staff? 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 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14950482
• MDR Text Key: 295471144
• Report Number: 3005075853-2022-04424
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002468
• UDI-Public: 10705036002468
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCL20
• Device Catalogue Number: MCL20
• Device Lot Number: 175A96
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2022
• 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
• Patient Outcome(s): Required Intervention; Death