MAUDE Adverse Event Report: AESCULAP INC STEAM STER LOCKS ORANGE; PROCESS INDICATOR LOCK

Model Number US906

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing site investigation is on-going.(b)(4).510(k) k890764.

Event Description

(b)(6).Customer reported that following processing of steril containers it was observed that the orange locks dots are changing back to blue.The customer stated that this caused a delay in surgery because they had to reprocess sets again.

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: serious injury and description updated.D: batch number updated.Multiple attempts were made for product return and investigation.(b)(4).Around 04/27/2017, the supplier schwarz stated that this was the only complaint on this lot number which they had recieved 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

Clarification was received: three cases identified that experienced surgical delay with patients under anesthesia: case 1 had a 25 minute delay (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 2, delay of approximately 2 hours (cc# (b)(4) ).- reported separately.Case 3, delay of approximately 2 hours (cc # (b)(4)).-reported separately.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: PROCESS INDICATOR LOCK
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa
• MDR Report Key: 6024500
• MDR Text Key: 57262848
• Report Number: 2916714-2016-00806
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 563744-01
• Distributor Facility Aware Date: 06/21/2016
• Date Manufacturer Received: 09/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other