MAUDE Adverse Event Report: AESCULAP AG TC IRIS SCISSORS CVD S/S 110MM; BASIC INSTRUMENTS

Model Number BC211R

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product at hand.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: no product available, therefore a conclusion and root cause cannot be conclusively defined.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 usage.Rationale: based on the quality standards and the device history record we exclude a material or manufacturer caused error.Without the product, we cannot determine the exact cause.If further investigations are required, the product should be provided for examination.No capa is necessary.If additional information is received a follow up report will be submitted.

Event Description

It was reported the tip broke intra-operatively.During a nasal surgical procedure the tip of the iris scissors broke while being used in the patient's nose.The surgeon found and retrieved the small piece with difficulty.An x-ray was performed to confirm that there were no remaining parts inside the nose.No other intervention or delay reported.No patient information has been provided.

• Brand Name: TC IRIS SCISSORS CVD S/S 110MM
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8480579
• MDR Text Key: 140876544
• Report Number: 9610612-2019-00193
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC211R
• Device Catalogue Number: BC211R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/14/2019
• Date Manufacturer Received: 03/11/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention