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

Catalog Number ER320

Device Problem Malposition of Device (2616)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2019.Batch # unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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.Just for clarification, the original surgery was done at doctors hospital of laredo.The post-op op surgery was done at the laredo medical center? how was it confirmed that the er320 was the device used to place the clips in the initial procedure? if confirmed the device was an er320, were there any issues with the device in the initial surgery? if yes, please explain.How was bleeding identified? if available, what is the lot number of the device? what was the color of the trigger? what is the current patient status?.

Event Description

It was reported that post-op to a laparoscopic cholecystectomy the patient presented the following day to a different hospital.During surgery it was discovered the cystic artery clips were not in place and there was internal bleeding.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was received: just for clarification, the original surgery was done at (b)(6) hospital of (b)(6).Yes.The post-op op surgery was done at the laredo medical center? yes.How was it confirmed that the er320 was the device used to place the clips in the initial procedure? physician to physician communication regarding the bring back complication (slipped clip).If confirmed the device was an er320, were there any issues with the device in the initial surgery? no.How was bleeding identified? when the patients were brought back to surgery.If available, what is the lot number of the device? we have multiple lot numbers and they were not documented.What was the color of the trigger? gray.What is the current patient status? as per md¿s the patients were recovered and discharged after meeting criteria.Is the device available for return? no.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8926820
• MDR Text Key: 155521405
• Report Number: 3005075853-2019-21484
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Patient Sequence Number: 1