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

Model Number 783100

Device Problems Misassembled (1398); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 2 open and used staplers.Analysis and results: there is one previous complaint regarding the same issue of this code-batch.There are no units in our stock.We have received two open and used staplers.Visual inspection of the returned staplers: returned stapler 1: the 24 pieces of staples were still inside the cartridge and in line correctly.Some blood were observed on the cartridge.The latch was hooked properly.Returned stapler 2: the 26 pieces of staples were still inside the cartridge and in line correctly.Some blood were observed on the cartridge.The latch was hooked properly.Reproducibility test - staple release test of two used staplers.Stapling release test with the returned staplers before disassembling.All the remaining staples inside the cartridge of the two used staplers were released without any problem.Disassembled components check of the returned staplers.Returned stapler 1: both corners of the anvil were worn.No problem was found with the components and measured values of each component of the stapler.Returned stapler 2: right side groove of the ram was deformed.Both corners of the anvil were worn.No problem was found with the components and measured values of each component of the stapler.As the results of the investigation, no problem was found with the production record or measured values of each component.Deformed and worn components such as anvil and ram were observed.However, reproducibility was not observed on the returned staplers.It is highly probable that an unexpected overload of pressure was applied to the product during application and some of the components were deformed, which caused the malfunctioning with an unexpected situation.Final conclusion: although reproducibility was not observed on the returned staplers, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.This report is being submitted late due to mis-interpretation of 2 year presumption acknowledgement and agreement by fda.Once issue was identified, retrospective review of complaints was completed from time of 2 year presumption implementation to present.All reports identified are being reported.

Event Description

Country of complaint: (b)(6).The staple when applied, both ends of the staple should be concentric.On defective machines, one tip is concentric, the other is not concentric.

• Brand Name: MANIPLER AZ - 35W SKINSTAPLER
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7531841
• MDR Text Key: 108893686
• Report Number: 3003639970-2018-00294
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 05/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 783100
• Device Catalogue Number: 783100
• Device Lot Number: U178030000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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