MAUDE Adverse Event Report: AESCULAP AG HENLY RETRACTOR SET COMPLETE 180MM; BASIC INSTRUMENTS

Model Number BV120R

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with bv120r - henly retractor set complete 180mm.According to the complaint description, it was reported that the henly retractor set complete 180mm was received and when inspected it was noted that the device came with some type of defect, reportedly, the bv120r one of the side blades was very difficult to put on.All other pieces seemed to assemble fine but this one felt like it was getting stuck.The device malfunction was noted on (b)(6) 2021.There was no patient involvement and the device malfunction did not cause or contribute to a delay in a surgery.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Updated: d4, d9- batch number, and product returned.After the product was received, it was determined to be a non-aag device.Therefore, aag is not legally responsible.Complaint will be forwarded to aesculap inc.

• Brand Name: HENLY RETRACTOR SET COMPLETE 180MM
• Type of Device: BASIC 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11693727
• MDR Text Key: 262692001
• Report Number: 9610612-2021-00325
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 04046963458645
• UDI-Public: 4046963458645
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/08/2022

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: BV120R
• Device Catalogue Number: BV120R
• Device Lot Number: 929128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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