MAUDE Adverse Event Report: AESCULAP AG PURSE STRING CLAMP; GENERAL SURGICAL INSTRUMENTS

Model Number EA323R

Device Problem 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: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the forceps (purse string clamp) was used for surgery.The suture did not hold, the forceps did not function properly.New operation was necessary due to lesion.All med watch submissions related to this report are: 9610612-2017-00083; 9610612-2017-00093.

Manufacturer Narrative

Correction made to: product code.Product code ffn.

• Brand Name: PURSE STRING CLAMP
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• 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: 6403573
• MDR Text Key: 70302085
• Report Number: 9610612-2017-00083
• Device Sequence Number: 1
• Product Code: FFN
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/15/2017
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other