MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 29MM CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH29A

Device Problems Break (1069); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem Surgical procedure (2357)

Event Date 08/26/2014

Event Type  Injury  

Event Description

It was reported that during a laparoscopic sigmoid procedure, the surgeon was using the cdh25a, fired the device, and was not sure if device fired staples.The surgeon then attempted to remove the device but could not remove it from the rectum.The surgeon converted to open procedure to push the stapler out, and with the stapler went a large amount of mucosa.The surgeon resected the colon and had to mobilize and ligate all the way up to the transverse colon.The surgeon then used the cdh29a to perform an anastomosis.When the anastomosis was tested, there was a leak, so the surgeon used a suture of unknown code (on an sh needle) to oversew the area.While oversewing the area, the tip of the suture needle broke off.The surgeon looked for the needle tip in the rectum and did not find it.An x-ray was done and no needle tip was visualized on x-ray.The case was completed and current patient status is unknown.

Manufacturer Narrative

(b)(4).At the time of this submission, the device has not been returned for analysis.If the device is received at a later date a supplemental medwatch will be sent.Additional information requested: what is the patient¿s current condition? what confirmation did the surgeon receive that the anvil was firmly attached? were any of the forces higher or lower than expected (closing, firing, or opening)? were any unexpected noises heard? what confirmation was received indicating the device was fully fired (such as crunch, compressed until unable to fire further, etc.)? did the washer get cut into two (2) pieces? were there two complete tissue donuts? was the instrument fired across or near an existing staple line or clip? were any unformed or malformed staples observed? how long has the surgeon been using this device for this procedure? who fired the device? assistant or the surgeon?.

Manufacturer Narrative

(b)(4).Information is unavailable; device was not returned for evaluation.Additional information received: what is the patient¿s current condition? patient went home.What confirmation did the surgeon receive that the anvil was firmly attached? unk.Were any of the forces higher or lower than expected (closing, firing, or opening)? unk.Were any unexpected noises heard? unk.What confirmation was received indicating the device was fully fired (such as crunch, compressed until unable to fire further, etc.)? unk.Did the washer get cut into two (2) pieces? unk.Were there two complete tissue donuts? unk.Was the instrument fired across or near an existing staple line or clip? unk.Were any unformed or malformed staples observed? unk.How long has the surgeon been using this device for this procedure? unk.Who fired the device? assistant or the surgeon? surgeon fired the stapler.

• Brand Name: ILS 29MM CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4092565
• MDR Text Key: 4763364
• Report Number: 3005075853-2014-06438
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDH29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention