MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOSUTURE SUTURE ASSISTANT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number SW100

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: 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.For product code sw112, a manufacturing record evaluation was performed for the finished device lot number p4ta31, and no non-conformance's were identified.Manufacturing date: 11/30/2017, expiration date 10/31/2022.For product code sw112, a manufacturing record evaluation was performed for the finished device lot number p4r03e, and no non-conformance's were identified.Manufacturing date: 1/4/2017, expiration date 12/31/2021.For product code sw100, the lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Per photographic evaluation: the first photo shows tissue from front side and it can be seen the cartridge plate on the tissue.The second photo shows two tyvek inside of a plastic bag from one tyvek belong to product code sw112, lot p4e03e with expiration date 2021-12-31, the second tyvek belong to lot # p4ta31 with expiration date 2022-10-31.The third photo shows a cartridge with the plate dislodged from top view and the suture piece present body fluids and the end appears to cut.In addition, the needle was not observed.The fourth photo shows a plastic bottle.Based on the photos reviewed, the event describe of cartridge assembly issue is confirmed.Based on the photos reviewed, the event described cannot be confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

Event Description

It was reported that during a laparoscopic j-tube placement, the doctor was using the endosuture with reloads, and after using one of the reloads, the doctor spotted a metal piece resting on some tissue.The piece was removed, inspected and found to be missing from one of the reloads.Upon closer inspection, a tiny piece of blue plastic was also seen.These pieces were all sequestered and put in a container.Later in the case, the device, itself, cut off two needles from the reloads, erroneously.There were two possible lot numbers this reload was from.It was not reported how the procedure was completed.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # r94r6p.Device analysis: the analysis results found that the sw100 device was received with no damage in the external components without a cartridge loaded, and two sw112 cartridges were received with the cartridge plate dislodged and with the suture cut.In addition, two tyvek (p4ta31,p4r03e) were returned along with the cartridge.Scratches were found in different areas of the cartridge body indicating that excessive force was used to introduced the asd instrument.The device was then reloaded with a test (n91103) cartridge and it was cycled, fired and it properly formed the knot.The potential reason of the loading or unloading failure can be caused due to incorrect instrument usage.A manufacturing record evaluation was performed for the finished device batch r94r6p number, and no non-conformances were identified.

• Brand Name: ENDOSUTURE SUTURE ASSISTANT
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8884713
• MDR Text Key: 154240743
• Report Number: 3005075853-2019-21189
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036002888
• UDI-Public: 10705036002888
• Combination Product (y/n): N
• PMA/PMN Number: K972679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: SW100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/15/2019
• Patient Sequence Number: 1