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

Device Problems Detachment Of Device Component (1104); Other (for use when an appropriate device code cannot be identified) (2203); Device Operates Differently Than Expected (2913)

Patient Problem Wound Dehiscence (1154)

Event Date 02/02/2017

Event Type  malfunction  

Event Description

Delay in reporting due to unable to locate the affected pt.Back on 02/27/2017, had filed a medwatch: (b)(4) and reported that there had been 3 incidence of staples falling out of pts incision requiring intervention.Was going to complete 3 different med-watches for each pt.The one listed above was completed.One would not locate who the pt was and then the third i could not confirm the pt as the chart did not reflect what was reported.Just found the one pt that we could not locate back in (b)(6).Found that on (b)(6) 2017 am the pt had a total abd.Hysterectomy with bso.No complication listed from surgery report, but the following morning (b)(6) 2017 at 0730, there is documentation that 2 staples were not attached to the skin and laying inside incision flap on left end of incision.These staples were removed, area cleaned and steri strips applied.Noted oozing serosanguinous from the area of incision as well as bruising.During the day the pt had developed complications.Returned to surgery the following day.Was discharged home on (b)(6) 2017.This was reported after surgery so the staples was not available to return and none of the lot or model number were available.Have been in contact with mfr with updated info and waiting on return call now.

• 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: 6541562
• MDR Text Key: 74412604
• Report Number: 6541562
• Device Sequence Number: 1
• Product Code: GDW
• 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: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/20/2017
• Distributor Facility Aware Date: 02/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2017
• 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: 34 YR