MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; ENDOSCOPY

Model Number PL569T

Device Problem Bent (1059)

Patient Problem Wound Dehiscence (1154)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the legs of the clip crossed, this caused a tear in the skin.A disposable clip had to be used to close the wound and stop the bleeding.Components in use listed as concomitant devices are: pl569t / ligating clips m/l 12 box, pl510r / handle f/pl506r & pl508r.

Manufacturer Narrative

Investigation: after the receipt of the products, the measurement of the devices was carried out by the quality assurance of the production department.Shaft pl538r: target current: *01* 67.80mm 67.78mm ok, *02* 10mm gauge ok, *03* 3.85mm 4.00mm ok, *04* 7.00mm 6.85mm ok, *05* 6.50mm 6.6mm ok.Inner rod pl538801: -out of service, -bent, -running rough, -slider sheet of the magazine is not pulled back-thus no feed of the magazine.Inner pipe pl538802: -out of service.Handle pl510r: -out of service.Magazine pl569t: -no clips remaining in the magazine.-"nose' broken off.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient maintenance of the device.Rational: no capa is necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6582396
• MDR Text Key: 75730394
• Report Number: 9610612-2017-00257
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K962493
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52308630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/08/2017
• Device Age: 3 MO
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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