MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE SKIN STAPLER; REMOVABLE (SKIN)

Catalog Number PRW35

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/30/2017

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.In what surgical procedure was the device used? was there abdominal distention following the procedure? was there an event or abdominal straining by the patient, such as coughing, sneezing, straining or an exertional movement? can you provide additional detail about the specific wound care that was provided to the patient prior to the steri-strip placement? what is the current patient status?.

Event Description

It was reported that during an unknown procedure, the staples were coming out of the patient too soon on their own.At the 48 hour mark they started to come out of the abdomen.There was no swelling or infection present.The patient received wound care and steri-strip placement.

Manufacturer Narrative

(b)(4).Batch # n57730.Additional batch information for the lot provided: batch #: p55x6a, manufactured date: 03/18/2017, product exp.Date: 02/18/2022.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.The analysis results confirmed that the prw35 device was returned with no apparent damage and fully functional.When tested for functionality the device fired and formed the remaining 37 staples as intended.The device fired without any difficulties and the staples were note to have the proper box shape.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: in what surgical procedure was the device used? c-section was there abdominal distention following the procedure? no swelling, edema or infection near the affected area while the staples were in place was there an event or abdominal straining by the patient, such as coughing, sneezing, straining or an exertional movement? no can you provide additional detail about the specific wound care that was provided to the patient prior to the steri-strip placement? the doctor said that the wound care management was only saline irrigation and dressing changes.Only some of the staples came out too early.What is the current patient status? patient doing well now.

• Brand Name: PROXIMATE SKIN STAPLER
• Type of Device: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6747866
• MDR Text Key: 81189773
• Report Number: 3005075853-2017-03859
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Catalogue Number: PRW35
• Device Lot Number: P91X4C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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