MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; SLIT KNIFE ANGLED, BEVEL UP

Model Number 72-2261

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

No samples were returned for evaluation.However photos of the knife were returned for review.There was no available stock of the blade component or the finished good lot available for review.The photos provided by the distributor were labeled as the knife utilized for the procedure reported.The image quality was not clear enough to identify uneven edges or defective tips as described by the end user.Without reviewing the exact device utilized by the surgeon for the procedure we could not confirm the problem reported.Relevant portions of the device history record were reviewed.The product from this finished good lot and all blade component lot met current requirements throughout the incoming inspection, manufacturing and final inspection processes.No other complaints were received from any other customers/end users who purchased this lot.Without receiving detailed information regarding the procedure performed or the surgeon's technique a definitive root cause for the deciment break or tears in the membrane can not be determined with certainty.

Event Description

It was reported that a deciment break occurred during a cataract surgery that required surgical intervention.The end user stated that nonequivalent edges on the knife were observed following the procedure which was determined to be the cause of the membrane tears because they made sure that the only thing that was different in the procedure was the knife.It was noted that the patient is not suffering from any affects from the procedure and all was clear at the post-op examination.No antibiotics were prescribed.Photos.Cataract surgery.Nonconforming edges were observed on the blade that resulted in membrane tears that required intervention.This event has been deemed reportable.

• Brand Name: SHARPOINT
• Type of Device: SLIT KNIFE ANGLED, BEVEL UP
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 7742664
• MDR Text Key: 115808738
• Report Number: 3010692967-2018-00012
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): Y
• Reporter Country Code: JO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Model Number: 72-2261
• Device Catalogue Number: 72-2261
• Device Lot Number: AABB780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 06/21/2018
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention