MAUDE Adverse Event Report: ETHICON ENDO-SURGERY PROXIMATE PLUS MD STAPLER 35W; ETHICON STAPLER

Device Problems Loose or Intermittent Connection (1371); Other (for use when an appropriate device code cannot be identified) (2203); Failure to Form Staple (2579)

Patient Problem Wound Dehiscence (1154)

Event Date 02/02/2017

Event Type  Injury  

Event Description

Recently there had been a reported total of 3 cases of staples falling out of patients incision requiring intervention.With this third case presenting and the same type of device used with the same surgeons, it was decided to place a med-watch due to patient safety concern.Delay in reporting event due to clarification of who holds manufacture responsibility as we do use reprocessed items.Clarified with operating room nurse manager who verified with staff that the stapler was not a reprocessed device but a new one.A (b)(6) female went for a tah lso on (b)(6) 2017 and the day after surgery the incision dehiscence.The surgeon was notified and came to the bedside and removed 15 midline staples that were loose and placed 15 sutures on incision at bedside.According to the physician discharge summary, the patient dehiscence for unk reason and the patient was at risk for dehiscence and infection but all looked well at discharge.The patient is to follow up with the surgeon a week after discharge.The surgeon did give more antibiotics after the closure.Patient was discharged home (b)(6) 2017.Unfortunately since this event occurred the day after surgery we do not have the packaging information or lot number.

• Brand Name: PROXIMATE PLUS MD STAPLER 35W
• Type of Device: ETHICON STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 6415253
• MDR Text Key: 70348307
• Report Number: 6415253
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2017
• Distributor Facility Aware Date: 02/02/2017
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR