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

Catalog Number ER420

Device Problem Difficult to Open or Close (2921)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # t9343c.Per photographic evaluation: upon visual inspection of two photos, the following was observed: the first and second photo show tissue with a clip no properly formed in the tissue.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.The complaint device was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number (t9367k), and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number (t9343c), and no non-conformances were identified.

Event Description

It was reported that during a lap cholecystectomy, the clips did not close.A second device was pulled for the case and the clips did not close.A drain was placed, and the case completed by over sewing the cystic duct.The following day on july 15, the patient was scheduled for ercp (endoscopic retrograde cholangio panography).Patient is currently at the facility.

Manufacturer Narrative

(b)(4).The following information was omitted on the initial report - 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 meant by ¿the clips would not close?¿ please provide information regarding the actual shape of the clips.What was done intra-op to address the clips that would not close? when the procedure was completed, were all clips confirmed to be on vessel, proper shape and providing proper occlusion? why did the surgeon place the drain? why did the surgeon over-sew the cystic duct versus using another clip applier? what lead the surgeon to schedule the ercp? what was found during the ercp? was there any medical or surgical intervention done during the ercp? what is the current patient status? why are there white stickers across the logo?.

Manufacturer Narrative

(b)(4).Additional information requested and received: the hospital cannot share any patient information about this case.The doctor explained that the clips were misaligned and would not close properly.They would not stay secured.The devise was removed from field and a new device was pulled and used.It was the doctors discretion to place a drain for any associate leaks that might happen in the future as a preventative measure.Additional photos were received for review.Upon visual inspection of the photos, the following was observed: the third and fourth photo show a clip no properly formed between the jaws of a surgical instrument.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8852297
• MDR Text Key: 153068504
• Report Number: 3005075853-2019-20939
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER420
• Device Lot Number: T9367K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Patient Sequence Number: 1