MAUDE Adverse Event Report: AESCULAP, INC. PURSE STRING CLAMP

Model Number EA323R

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Us reporting agent notified on: 08/10/2015.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).After piercing the needle straight through both branches, opening the clamp and pulling the purse string suture, it was noticed that the mucosa was only partially punctured and thus there is a seam insufficiency.(the instrument has been used twice).

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 ea323r purse string clamp.The instrument shows no visible damages.This instrument is manufactured according to the factory sample.Test with silk paper, according to the test paper: the silk paper is put into the clamp, which is closed completely for at least 2 seconds.After opening the clamp, the impression of the longitudinal profile must be fully visible and must not show perforation.Final conclusion: complaint is not justified.Based on our investigation the failure is not manufacturing related.Most likely the failure is handling related.The instrument doesn't show any deviations from the specifications.Also the carried out test with silk paper was passed successfully.Corrective/preventive actions: not applicable.

• Brand Name: PURSE STRING CLAMP
• Manufacturer (Section D): AESCULAP, INC.; tuttlingen ; GM
• Manufacturer (Section G): AESCULAP, INC.; po box 40; tuttlingen ; GM
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5032868
• MDR Text Key: 24690719
• Report Number: 2916714-2015-00727
• Device Sequence Number: 1
• Product Code: HXD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EA323R
• Device Catalogue Number: EA323R
• Device Lot Number: 4505602136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other