MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Model Number	CS40B
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Form Staple (2579); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information received: due to the cut with no staples, the surgeon converted to an ils stapler.According to the surgeons, due to the lack of tissue after the ils stapler was used, a leak was observed.The surgeon performed a diverting loop ileostomy and will be bringing the patient back to surgery later to try and complete procedure.On january 12th the surgeon did a sigmoidectomy.On the second firing of the device, no staples were laid and the device cold cut.The surgeon did mention that there was a new tech in the room.There was a second reload opened but it could not be confirmed if the device was properly loaded.The surgeon converted to an ils stapler and after use of the ils stapler the patient had a leak, and a loop ileostomy was created.The device is used for the distal transection in creating the rectal stump.It cannot be confirmed if the distal transection was completed in one or multiple firings.It was shared that the surgeon should be familiar with reloading the device and the surgeon does the firing and fires plastic to plastic.At this time, it is unknown if the retaining pin is set automatically or manually or when the retaining cap is removed.It is unknown if there was difficulty in closing or firing the device.Surgeon experience with device? 5 plus years.Are surgical procedure or device/videos available? no.Surgeon declined meeting with ethicon medical and engineering.Additional information was requested, and the following was received: please provide the product code for the device that was used in the procedure.What is the lot number? cs40b.No lot available.Is the loop ileostomy temporary or permanent? temporary.Did the patient receive any preoperative chemotherapy or radiation? no.Who reloaded the device and what is their experience? surgical tech, traveler unknown experience.Was there any difficulty in reloading? yes, the first assist in the room recalled some difficulty with reloading, could not elaborate further.What was done to ensure that the cartridge was snapped in prior to closing the device? unknown.How was the retaining pin placed (manually or automatic)? automatic.How did the user confirm that the pin was in the proper orientation before firing? first assist in room stated they visually confirmed pin was in place.When was the staple retaining cap removed? unknown.What provisions did the surgeon take to ensure the tissue was lying evenly within the jaws? first assist in room stated surgeon always tries to visualize tissue is flat.Was the device difficult to close? no.Was the device closed and repositioned multiple times prior to firing? no.Was the device difficult to fire? no.Was the distal transection completed in one or multiple firings? 1 firing.First firing was proximal resection, 2nd was distal.Can more information be provided about staple form? first assist stated some malformed staples on removed specimen side, none on other side (remaining distal rectum).Surgeon stated no staples were seen and it was a ¿cold cut¿.Slightly conflicting recollections.What is the current status of the patient? waiting to bring back to reverse loop illeostomy.
Event or Problem Description
It was reported that during the colorectal procedure, the surgeon fired a contour stapler for the second time.When the surgeon opened the device, the device had cut but no staples were laid down.There was other medical intervention and was unable to confirm if the device was properly reloaded between firings.The surgery was delayed by 10 minutes.There were no patient consequences.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13892704
• Report Number: 3005075853-2022-01798
• Device Sequence Number: 15042241
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (Y/N): N
• PMA/510(K) Number: K040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CS40B
• Device Catalogue Number: CS40B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown