MAUDE Adverse Event Report: BOLDER SURGICAL JUSTRIGHT 5MM STAPLER; SURGICAL STAPLER

Model Number JR-ST25-2.0

Device Problem Failure to Form Staple (2579)

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

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

The device history record for lot 75aa0406 was reviewed.No anomalies were noted on the lot release paperwork.The device was not returned, without a product return, no product evaluation is able to be conducted.The current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that during a zenker's diverticulum procedure, the staples did not form, and the surgery was converted from lap to open to finish the case.The patient was reported to be fine postoperatively.No further patient or procedural information was provided.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: SURGICAL STAPLER
• Manufacturer (Section D): BOLDER SURGICAL; 331 s 104th st; ste 200; louisville CO 80027 9717
• Manufacturer (Section G): BOLDER SURGICAL; 331 s 104th st; ste 200; louisville CO 80027 9717
• Manufacturer Contact: brad greathouse ; 331 s 104th st; ste 200; louisville, CO 80027-9717 ; 9792270102
• MDR Report Key: 11978269
• MDR Text Key: 255681745
• Report Number: 3010377594-2021-00005
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75AA0406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention