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

Model Number 783100

Device Problem Difficult to Open or Close (2921)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 6 unopened units and 2 opened.Analysis and results: there are no previous complaints of this code-batch nor units in stock in our warehouse.We have received six closed samples and two opened.Visual inspection of the returned staplers (used samples): returned stapler 1: 16 pieces o staples were still inside the cartridge and in line correctly.Returned stapler 2: 20 pieces of staples were still inside the cartridge and not uniform.Unhooked latch was observed.Disassembled components check of the two used staplers 1 and 2: some blood was observed inside the cartridge of stapler 1.Right grooves of rams from both staplers were deformed.No problem was found with the components and measured values of each component of the stapler.Reproducibility test - staple release test of the two used staplers: stapling release test with returned staplers before disassembling.Used stapler 1: the 4th staple from the remaining staples in the cartridge of the used stapler 1 was released in a deformed shape but the rest of remaining staples were released without any problem.Used stapler 2: remaining staples in a cartridge of the used stapler 2 were released is a deformed shape due to unhooked latch.Stapling function did not work properly if the latch was unhooked.Stapling release test with returned staplers with replaced component such as ram after reassembling.All the staples of both staplers were released without any problems.Stapling function performed properly.As the results of the investigation, no problem was found with the production record or measured values of each component.Reproducibility was observed on stapler 2 due to the unhooked latch, and right grooves of both rams from the returned stapler 1 and 2 were deformed.Since 100% inspection in the staple release test is conducted before shipping, it is easily found is the latch was unhooked.Also, it has not seen any scratches or damages on the latch part of the cartridge so that it might happen during the return.It is highly probable that an unexpected overload of pressure was applied to the product during application and the rams were deformed causing the malfunctioning.On the other hand, the closed units received have been tested and reproducibility was not confirmed.The stapling function performed properly.Furthermore, no problem was found with the measured values of each component of the closed samples received.Final conclusion: although the results of the samples received fulfil the product specifications, 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).It was reported that the clips did not close properly.

• 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: 7531877
• MDR Text Key: 108891594
• Report Number: 3003639970-2018-00292
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/21/2018

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: 03/19/2018
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 02/26/2018
• 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