MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 21MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH21A

Device Problems Crack (1135); Failure to Form Staple (2579); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint: (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 following information was requested, but unavailable: how far was the width of the dissection was expanded? no further information is available.How long was the operation time prolonged? no further information is available.Was the hospital stay prolonged beyond what is typical for this type of procedure? if so, why? no further information is available.Was there any patient consequence or change to the post-operative care of the patient as a result of the event? no further information is available.

Event Description

It was reported that during a laparoscopic sigmoidectomy, the target tissue of oral side was uncut and not stapled.The device was used for dst anastomosis between the colon and the rectum.The firing force was higher than expected at the firing, but the breaking sound of the washer was heard.The unstapled tissue was cut again, and another device was used to complete the case.Therefore, the width of the dissection was expanded, and the operation time was prolonged.The patient is hospitalized.The patient had just been hospitalized for a day, and complications were not observed.It was found that there was a crack on the washer, but the washer was uncut when the sales rep checked the device after the procedure.No further information is available.

Manufacturer Narrative

(b)(4).Batch # r5762r.Per photographic evaluation: the photo shows a device from top view of label area with the anvil detached.It was noted that the safety is disengaged and broken, since it was observed a piece of it.The washer can be appreciated inside of the anvil and appears to be cut.Based on the photo alone the event describe cannot be confirmed.Please refer to the device analysis for full analysis details and conclusion.Device analysis: the analysis results found that the cdh21a device arrived with the safety damage.The breakaway washer was present and cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples and tested for functionality; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.It appears that an attempt was made to fire the device with the safety engaged.It should be notice that to fire the device, draw the red safety back toward the adjusting knob until it seats into the body of the device.If the safety cannot be released, the device is not in the safe firing range.Please reference the instructions for use for additional information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ILS 21MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8578052
• MDR Text Key: 144332959
• Report Number: 3005075853-2019-18712
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003441
• UDI-Public: 10705036003441
• Combination Product (y/n): N
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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: 09/11/2023
• Device Catalogue Number: CDH21A
• Device Lot Number: R5762R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1267-2019
• Patient Sequence Number: 1