MAUDE Adverse Event Report: AESCULAP AG IRIS SCISSORS CVD.S/S 110MM; GENERAL SURGICAL INSTRUMENTS

Model Number BC061R

Device Problem Material Fragmentation (1261)

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

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

User facility mdr report # mw5110783.Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That iris scissors cvd.S/s 110mm (part # bc061r) were used during a procedure performed on (b)(6) 2022.According to the complainant, the curved iris scissors broke in the patient's nose while surgeon was performing nasal surgery.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aic reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

Investigation complete.

• Brand Name: IRIS SCISSORS CVD.S/S 110MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15260727
• MDR Text Key: 298285755
• Report Number: 2916714-2022-00088
• Device Sequence Number: 1
• Product Code: LRW
• UDI-Device Identifier: 04038653020324
• UDI-Public: 4038653020324
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/19/2022,10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC061R
• Device Catalogue Number: BC061R
• Device Lot Number: 19063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2022
• Distributor Facility Aware Date: 07/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention