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

Model Number ER320

Device Problems Mechanical Jam (2983); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure the ligaclip device did not set the clip on the clipper rail.The procedure was successfully completed.There were fragments generated but they were easily removed.The patient did suffer from arterial bleeding.

Manufacturer Narrative

Pc-(b)(4).Date sent:(b)(6)2022.Batch # u94p4t.Investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the er320 device was returned with the top shroud cracked and a clip in jaws.The clip was removed in order to inspect the jaws and they were found with no damage.In addition, the packaging opened was returned.No functional test could be performed due to the condition of the returned device.The device was disassembled in order to evaluate the condition of the internal components and no anomalies were noted.In addition, 12 clips were found inside clip track.It could not be determined what may have caused the damaged found; however, it is known from the history of the device that the condition of the shrouds may lead to ejected clip.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Additional information was requested, and the following was obtained: please provide more details, did the device cut the vessel? i do not have this information, how was bleeding controlled? doctor did not tell what amount of blood loss (mls) occurred? not informed was there any change to the procedure as a result of the event? no.What is the current status of the patient? already discharged from the hospital please confirm, have any parts fallen into the patient? by medical report, no.Only the clip did not close.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.

• 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 ; * ; 329348013
• MDR Report Key: 15234043
• MDR Text Key: 305246178
• Report Number: 3005075853-2022-05320
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

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: ER320
• Device Catalogue Number: ER320
• Device Lot Number: U40K1R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1