MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE ILS CIRCULAR STAPLERS; STAPLE, IMPLANTABLE

Catalog Number CDH29A

Device Problem Cut In Material (2454)

Patient Problem No Code Available (3191)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: what healthcare professional fired the device and what is his/her experience? surgeon is experienced with our product.Were there any staple formation issues noted in the surgical field? if so, please describe the shape of the staples.With irregular shape.Did the device cut the tissue? yes what is the current patient status? stable and left from the hospital.

Event Description

It was reported that during a laparoscopic low anterior resection (dixion), the orange indicator was in the green range,could not squeeze down the firing trigger and the breakaway washer was cut a half.Changed to an open surgery and suture was used to sew the wound, made a temporary fistula.The surgery as delayed about 4 or 5 hours.The patient is stable and in the hospital.

Manufacturer Narrative

(b)(4).Additional information obtained: after removed from the patient, the surgeon found the adjusting knob was loose, could not rotate any more.Corrected data - device evaluation: the analysis results found that the cdh29a device (b) arrived with no apparent 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, a new washer was placed on the device and it was tested for functionality.It fired and 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.No issues were noted on the adjusting knob, the device opened and closed as intended.

Manufacturer Narrative

(b)(4).Batch # p56g1f.Device evaluation: the analysis results found that the cdh29a device arrived with no apparent 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, a new washer was placed on the device and it was tested for functionality.It fired and 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 batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: PROXIMATE ILS CIRCULAR STAPLERS
• 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: 6908499
• MDR Text Key: 87980664
• Report Number: 3005075853-2017-05258
• Device Sequence Number: 1
• Product Code: GDW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2022
• Device Catalogue Number: CDH29A
• Device Lot Number: P4RE2P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 46