MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MANIPLER AZ - 35W SKINSTAPLER; MECHANICAL SUTURES

Model Number 783100

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaints: (b)(6).Due to this fact the weld doesn't hold and get loose (open it).Customer assume a problem with the batch.

Manufacturer Narrative

Samples received: there are no samples nor batch number available.Analysis and results: complaint history record cannot be checked as the batch number was not available.Checking stapling angle: stapling with two types of materials at 90 degrees angle and check the stapling condition every 10 degree angle from the upper limit to the lower limit.Test materials and conditions: silicone sheet (degree of hardness is 60 degrees).Polyurethane rubber.Test material with silicone sheet: sample stapler was able to release staples and hold the materials at 80 degree angle to 140 degree angle.Test material with polyurethane rubber: sample stapler was able to release staples and staple the materials at 70 degree angle to 150 degree angle.Investigation summary: there are no similar complaint reports concerning manipler az in the past.It is assumed that it is likely that the end user(s) stapled staples at diagonal direction more than 140 degrees angle or less than 80 degree angle.Therefore, staples were not in the skin deep enough nor held the wound properly.Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.Final conclusion: complaint is not justified.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.Additional information surrounding report event: when applying clips during surgery, the clip fired at a diagonal angle.Due to the angle of the clip, it would not hold correctly and became loose.

Event Description

When applying clips during surgery, the clip fired at a diagonal angle.Due to the angle of the clip, it would not hold correctly and became loose.

• Brand Name: MANIPLER AZ - 35W SKINSTAPLER
• Type of Device: MECHANICAL SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5660829
• MDR Text Key: 45336985
• Report Number: 2916714-2016-00390
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 783100
• Device Catalogue Number: 783100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/12/2016
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Other