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

Model Number ER320

Device Problems Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: what was the initial procedure? what anatomical structure were clips applied to? was there any twisting, torquing, or downward pressure placed on device during firing of clips? were there any clip malformations noted during initial procedure? did the patient have any medical condition or co-morbidity that could affect condition of tissue? what was the timeline of events (meaning how long after procedure was it before leakage was discovered)? how was leak discovered/diagnosed (were any scans or studies performed)? what specific intervention or treatment was provided to patient? what is the patient's current status? what are the lot/batch number for the device of issue? is the complaint device available to return for analysis? was there an issue with the er320 device having clips fall off tissue during the initial procedure? if not, what was the specific issue for the er320 device? is video of the procedure available (and if so, please provide the video)? 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 an unknown procedure, the device didn't work.It seems it is applying decent clips in the operation area however when touched, the clips easily gets removed and fell down from the tissue they were combining.The patient returned to hospital due to leakage and intervention was required.

Manufacturer Narrative

(b)(4).Date sent: 01/20/2022.Batch # u95m21.Video received and is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was received: what was the initial procedure? / laparoscopic pouch surgery what anatomical structure were clips applied to? / cystic canal was there any twisting, torquing, or downward pressure placed on device during firing of clips? / no were there any clip malformations noted during initial procedure? / no did the patient have any medical condition or co-morbidity that could affect condition of tissue? / no what was the timeline of events (meaning how long after procedure was it before leakage was discovered)? / right after the application how was leak discovered/diagnosed (were any scans or studies performed)? during clipping, the tissue couldn't be cut due to the clips not holding the tissue.Because clipping couldn't be guaranteed, the prevention tried to happen before leakage what specific intervention or treatment was provided to patient? / another brand was used to complete the surgery what is the patient's current status? are the complaint devices available to return for analysis? / yes was there an issue with all four of the er320 devices having clips fall off tissue during this initial procedure? / visual and mechanic functions didn't seem faulty.All features were controlled before using on the patient.If not, what was the specific issue for each of the four er320 devices reported on this complaint? / the clips not holding the tissue is the video of procedure available(and if so, please provide the video)? the comparison video with the mdt firm during the surgery is attached.In the video, the surgeon is first using the device of mdt firm and showing how he is applying clips.After 2 clips while saying "look how i clip, i can move the device however i want, and then clip", he switches to ees device and applies one clip.Then he easily removes the clip from the tissue and says "see? i didn't even forced the clip to come out" and them he uses the mdt device and applies another clip and tries to remove the clip and it doesn't come off.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.Did this patient return to the hospital at a later time or date due to a leak (after the initial procedure had already been completed)? or was the potential for a leak discovered during the initial procedure and another manufacturer's device was used in order to prevent a leak from occurring during this same initial procedure (therefore no re-hospitalization or re-operation was required)? device analysis: the product was returned to ethicon endo surgery 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 no apparent damage.The device was tested for functionality.During the analysis, the device was noted with fluids.The device was functional tested, and it fed, retained and formed the remaining 18 clips as intended.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number u95m21, and no non-conformances were identified.Mfg date: 10/30/2020 exp date: 09/30/2025.

Manufacturer Narrative

(b)(4).Date sent: 2/22/2022.H2: additional information received: the issue was discovered right after the application of the device.Another device was used to complete the procedure.Did this patient return to the hospital (after initial procedure was already completed) for reoperation due to leakage? no.Or was surgeon able to control leakage during the initial procedure, and therefore no reoperation was required? the surgeon had it under control.No reoccurrence was seen.Upon review of the additional information provided above, it was concluded that this event no longer meets the fda defined criteria for an adverse event of serious injury and file is being downgraded to a malfunction.See corrected data in h11.H1: type of reportable event: mdr decision is now a malfunction.H6: health effect - clinical code: e2403.H6: health effect - impact code: f26.H6: medical device problem code: a25; a0507040.

Manufacturer Narrative

(b)(4) date sent: 2/25/2022 h2: no additional information video was received on this device.This was reported in error on 3005075853-2021-08006 follow up number 1.The video was actually received and reported under 3005075853-2021-08007 (follow up number 3).

• 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: 13048809
• MDR Text Key: 286457724
• Report Number: 3005075853-2021-08006
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• 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,Followup,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention