MAUDE Adverse Event Report: AESCULAP INC STEAM STER LOCKS ORANGE; STERILE TECHNOLOGY

Model Number US906

Device Problem Defective Component (2292)

Patient Problem No Code Available (3191)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.(b)(4).Multiple attempts were made for product return and investigation.Suppliers identified: (locks) (b)(4).Around 04/27/2017, the supplier (b)(4) stated that this was the only complaint on this lot number which they had received for brittle locks, and they would continue to monitor for this issue.The company also determined that the adhesive on the dots was not strong enough; and requested sample roll of dots from sps with a stronger adhesive so they could manufacture test samples and measure adhesion force.This issue was also monitored.

Event Description

It was reported that there was an intraoperative malfunction of the oranbe locks.Three cases identified that experienced surgical delay with patients under anesthesia: case 3 had a delay of approximately 2 hours( this complaint).The reporter stated that some locks and dots were breaking or falling off during storage and transport, and not that the indicator dots on the locks were changing color.Further patient details were not provided.Case 1 had a 25 minute delay (cc# (b)(4)).- reported separately.Case 2 had a delay of approx.2 hours (cc # (b)(4)).-reported separately.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley, pa
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, pa
• MDR Report Key: 10010764
• MDR Text Key: 194314607
• Report Number: 2916714-2020-00154
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 563744-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other