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

Model Number ER420

Device Problems Failure to Fire (2610); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Attempts are being made to retrieve the device.To date, no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during an appendectomy procedure, a ligaclip was opened intra-op, the surgeon fired the device, and applied the clip without any issues.On the second firing, the device ripped the vein without applying any clips.The surgery was intended to be laparoscopic, but was switched to an open surgical procedure.The client told the sales rep that the device was used for the first time and it came without any clips inside, however upon the interview with the surgeon, it is not certain if the device was used after re-sterilization.The surgeon has good level of information regarding the device but surgeon said he didn't examine the device before use so he wasn't sure if this one was re-sterilized or not and the surgeon didn't pay attention regarding whether the device was running out of the staples or if had already run out.It was reported re-sterilized devices were probably used and was assumed the device was re-sterilized.Though converted to open procedure, no patient consequence has been confirmed by the surgeon.

Manufacturer Narrative

(b)(4).Date sent: 11/8/2021.D4: batch#: t92t7a.Investigation summary: the analysis results found that the er420 device was received with no damage to the external component.Upon cycling, the device was noted to be empty.The instrument was disassembled in order to evaluate the condition of the internal components and no damages were noted in the internal components.Due to the returned condition of the device, no functional testing could be performed to evaluate the reported incident.No signs were observed that the device was resterilized or reprocessed.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: 12573900
• MDR Text Key: 274710206
• Report Number: 3005075853-2021-05917
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: U95X7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention