MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH33A

Device Problems Crack (1135); Firing Problem (4011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p55x46.Device evaluation: the analysis results found that the cdh33a device arrived with no apparent damage.The breakaway washer uncut and indented and there were no staples present.The device was reloaded with staples and tested for functionality with a test washer; 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 were noted to have the proper b-formed shape.The condition of the washer indicates that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range.It should be noted that before firing the device the orange indicator should be fully within the green range of the gap setting scale.In addition, it should be noted that if the firing sequence is not complete (the firing handle reaches its stopping point, and the firing trigger is parallel to the instrument handle) staples could be partially deployed without cutting the washer.Please reference the instructions for use for additional information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a colectomy procedure, the surgeon was unable to fire the device with a crack sound.The surgery finally finished the anatomosis by hand suturing.There were no patient consequences reported.

• Brand Name: ILS 33MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7810142
• MDR Text Key: 118255693
• Report Number: 3005075853-2018-12313
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036003479
• UDI-Public: 20705036003479
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2018

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: 08/27/2022
• Device Catalogue Number: CDH33A
• Device Lot Number: P4T30G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1