MAUDE Adverse Event Report: AESCULAP AG PURSE STRING CLAMP 60MM JAW 280MM; STOMACH AND INTESTINAL FORCEPS

Model Number EA323R

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Investigation results: the products have been received in a used and decontaminated condition.Investigation was carried out visually and microscopically.A functional testing has been performed.Furthermore the clamp has been reviewed together with r&d and product management, the product was found to be according to specifications.This failure is a known phenomenon that can occur during surgeries and is covered by the risk analysis.The customer stated that the aesculap clamp in comparison to the ethicon clamp does not perform comparable.With ethicon clamps such failures haven't been provoked.In internal tests it could be confirmed, that the ethicon purse string clamp performs in worst case conditions better than the aesculap purse string clamp.If in this case a worst case is given it cannot be determined only on the basis of the pictures.The ethicon clamp shows two differences.The position of the pinholes who are guiding the needle is closer to the teeth of the clamp, the measured distance from outside part of both holes is in case of aesculap 4,65 mm and in case of ethicon 3,65 mm.The geometry of the teeth is rounded and not straight as in case of aesculap.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based upon our investigation and the information available the root cause is most likely a combination of a patient related influence, representing a worst case, and design related influences which do not allow to perform adequately in case of worst case.As internal tests confirmed, the ethicon purse string clamp design shows better results in worst case conditions.It is possible, that the surgery was such a worst case condition and therefore the purse string suture could not be applied as required.A capa has been initiated.

Event Description

It was reported that there was an issue with a purse string clamp.According to the complaint description: " despite complete closure of the clamp the tissue could not be pierced 100%, so that it was necessary to place a second suture.Additional to the aesculap clamp a purse string clamp from ethicon has been sent for comparison.Customer claims that the ethicon purse string clamp has a better and more secure performance.No additional information received.The adverse event is filed under aag reference (b)(4).

• Brand Name: PURSE STRING CLAMP 60MM JAW 280MM
• Type of Device: STOMACH AND INTESTINAL FORCEPS
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8857465
• MDR Text Key: 153164083
• Report Number: 9610612-2019-00528
• Device Sequence Number: 1
• Product Code: HTD
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EA323R
• Device Catalogue Number: EA323R
• Device Lot Number: 4509995657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention