MAUDE Adverse Event Report: TELEFLEX MEDICAL DEROYAL SURGIMATE 35W 24/ CASE; STAPLER

Catalog Number 528435

Device Problems Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Complaint alleges that the skin stapler has jammed.There was no information given on the patient's condition.

Manufacturer Narrative

(b)(4).A device history record (dhr) review did not show issues related to complaint.Complaint cannot be confirmed since the sample was not available for investigation; therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.However, the manufacturer will continue to monitor and trend relating complaints.

Manufacturer Narrative

(b)(4).One (1) stapler from catalog number 528435 deroyal surgimate 35w (b)(4) case was received used, opened without the original packaging and the lot# was not confirmed.During visual inspection, the components look well assembled and no staple was stuck in the tip of the cartridge.The stapler was received with remaining staples; staples was not observed misaligned and a cracked bottom component.Failure mode jamming was not confirmed with sample received during visual inspection.Despite the condition when the sample was received with a cracked bottom component, a functional inspection was performed with remaining staples (14).There was no quality issues were found during the activation, the device works properly; staples closed & released properly.Therefore, corrective actions are not required at this time.However, the manufacturer will continue to monitor for trends.

Event Description

Complaint alleges that the skin stapler has jammed.There was no information given on the patient's condition.

• Brand Name: DEROYAL SURGIMATE 35W 24/ CASE
• Type of Device: STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: doris sturgis ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334953
• MDR Report Key: 4860271
• MDR Text Key: 5847108
• Report Number: 3003898360-2015-00444
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/21/2019
• Device Catalogue Number: 528435
• Device Lot Number: 73L1400337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1