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

Model Number ER420

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dehydration (1807); Inflammation (1932)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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: what is the surgeons standard protocol for pre, intra and post operative iv fluids? what if any was the additional treatment the readmitted patient received?.What is the surgeon¿s experience with slr?.What evidence has the doctor provided to suggest that these patients may have had more inflammation than normal?.Were any scans or testing done to show the inflammation or were abnormal lab values noted that would be indicative of inflammation?.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 post op to the sleeve gastrectomy procedure, patient has recently experienced post-op dehydration that required iv fluids.Patient was readmitted for care.The doctor explained that the dehydration was due to more inflammation.The doctor believes that more inflammation than usual was caused by ethicon staple line reinforcement.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2022.Additional information was requested and the following was obtained: "thank you for reaching out! i understand and appreciate how seriously this process is taken.I¿ve reached out to the surgeon for more information multiple times but he did not provide any additional information.Also, the or manager and chief of surgery were not aware of these patient incidents and could not provide further information either.However, i do know that the surgeon used ethicon staple line reinforcement from (b)(6)2020-(b)(6) 2021 without any of the issues that he reported (b)(6) 2022.I will be sure to share any additional information as it becomes available.Please let me know if you need anything else from me in the meantime.".

• 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 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15681146
• MDR Text Key: 302498037
• Report Number: 3005075853-2022-07301
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2022
• 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): Hospitalization